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In an effort to expedite publication in the Orange Book of patent information for recently approved new drug applications, OIT's Division of Data Management and Services has posted a patent submission sample format on the CDER Internet site.
The sample format is available in both HTML and PDF formats and can be found at:
Previously, drug companies had to rely solely upon the Code of Federal Regulations (21 CFR 314.53) to determine information to be submitted to the Agency regarding their patents.
Although the regulation indicates the data elements needed, no format was included for the submitting data. This resulted in incomplete submissions. Timeliness of patent submissions is a critical factor in the generic drug approval process.
A PDF document containing information from CDER's patent and exclusivity database is posted on the CDER Website under regulatory information and contains the most current patent and exclusivity information.
This information is also available in a drilldown from any of the search categories of the Electronic Orange Book. In addition, the data files used to create the patent and exclusivity information for the Electronic Orange Book are available on the Internet as part of the Electronic Orange Book data set.
The OIT point of contact is Mary Ann Holovac, R.Ph. (HOLOVACM).
By Gloria Marquez Sundaresan
May, designated as Asian Pacific American Heritage Month, once again brings attention to the annual presidential proclamation that recognizes Asian Pacific American contributions to this country.
In the late 19th century immigrants from China began arriving to this country. They were later followed by the Japanese, Filipinos, Koreans, Asian Indians and other Asian groups. In the past, Asians provided labor and support to the growing railway and agricultural industries. The Chinese provided intensive labor in the completion of the western half of the first transcontinental railway, a badly needed link to the Pacific. The Japanese and Filipinos provided labor in pineapple farms in California and Hawaii.
Today, the contributions of Asian Americans are felt in all aspects of American life, including health care, national defense, academia, public service, education, sports, Congress, finance, arts, information technology and space exploration.
For years the sons and daughters of immigrants from Asia shared their creative talents, skills and dedication to make this country great. In science, David Ho stands out as Time magazine's 1996 man of the year for his research on the AIDS virus that gained international recognition. For skating enthusiasts, there is the sheer joy of watching Michelle Kwan and Kristi Yamaguchi twirl and momentarily suspended in space. Both have dominated the Olympic figure skating competition.
On the golf course, we have Tiger Woods and Vijay Singh. In public service we have seven Asian Pacific Americans in Congress; Gary Locke, governor of Washington State and the first Asian American elected to head a mainland U.S. state; and Yvonne Lee, one of eight commissioners of U.S. Commission on Civil Rights.
The Boston Symphony Orchestra has two renowned Asian members: its director, Seiji Ozawa and cellist, Yo-Yo Ma. NASA employee Kalpana Chawla holds a doctorate in aerospace engineering and is a member of the Columbia Space Shuttle. Not to be forgotten are Asian Pacific American soldiers who fought in the different wars that this country was involved in defending freedom all over the world. In business, more and more Asian Pacific Americans are joining the list of CEOs including Thinh Tran, Charles Wang and Yahoo! co-founder Jerry Yang.
Today, HHS has an APA group working to implement the White House Asian American and Pacific Islander Initiative, which was signed by President Clinton in June 1999. Members of this group include Shamina Singh who is the executive director and her staff: Ruby Lam, Charmaine Manansala, Lisa Hasegawa, Christie Onoda, Neolani Kayetani and Angie Comeau. This group works hard to improve the participation of Asian Pacific Americans in federal programs as well as their quality of life in the federal sector and the community.
To observe the APA Heritage Month, CDER set up a display, "APA Women of Hope," honoring Asian Pacific American women who have made a significant contribution to this country. In addition, the Center participated in a one-day APA Heritage Month program and leadership training conference held May 25 in Parklawn.
At present, Asian Pacific Americans make up about 3.8 percent of the U.S. population. By 2050, one in 10 Americans can be expected to trace their heritage to Asian Pacific Americans.
Gloria Marquez Sundaresan is a member of the Center's EEO Staff
The Reviewer Affairs Committee received 200 responses to its survey on the status of the group. There were 177 votes in favor of continuing the RAC and 23 votes for disbanding it. Many of those voting to continue the committee expressed a desire that it function in its traditional way.
The Center would like to honor reviewers' preferences; however, discussions with the NTEU have to take place before a final decision can be made. CDER management, RAC leadership and the NTEU are engaging in discussions on how best to proceed.
On March 29, the Design Team and Best Practices Subcommittee held its second workshop. Individuals responsible for the success of this event were co-chairs Jean Yager and RAC representative Sousan Altaie along with workshop facilitators Deborah Kallgren, Fred Marsik, Lana Pauls, Luqi Pei and Mary Jane Walling.
This group has identified the qualities of successful and unsuccessful multidisciplinary review team. Some of the topics discussed included preparedness of the team, mutual respect between disciplines, proper documentation of meetings, decision-making skills, communication and the influence that leadership has on the team. Additional details will be provided in the near future.
The Comparable Pay Subcommittee would like to remind the disciplines to contact their RAC representatives or send an e-mail to the RAC account to obtain information on how to approach the possible implementation of comparable pay within a discipline.
CDER celebrated support staff excellence March 8 when Patricia Tuegel was presented with the first Quarterly Support Staff Award. Members of the Support Staff Coordinating Committee surprised Patricia at work with balloons, a plaque and a time-off award.
Patricia's supervisor, Peter Cooney, Ph.D., associate director for microbiology in the Office of New Drug Chemistry, said of her in his award recommendation: "Her performance in this position has exceeded the highest standards of leadership, innovation and professionalism."
The Quarterly Support Staff Award is part of committee's ongoing mission to recognize and reward outstanding performance by Center staff.
By Mei-Ling Chen, Ph.D.,
and Yuan-yuan Chiu, Ph.D.
In June 1998, CDER established the Complex Drug Substances Coordinating Committee as the primary body to coordinate scientific and technical issues related to complex substances that are contained in drugs or used to manufacture drugs and are regulated by the Center.
The committee defines complex drug substances as:
Many of these complex drug substances are natural products extracted from plants or from organs, tissues or the body fluids of animals or humans (except human blood).
Unlike drugs that are made of purified, small molecules, complex drug substances are difficult to characterize chemically. In certain cases, a product is defined by its manufacturing process, and a product can be process specific. For these reasons, it is challenging both scientifically and regulatorially to determine if complex drug substances are comparable before and after manufacturing changes or to decide if they are therapeutically equivalent when they are made by different firms.
It is equally challenging to determine the "sameness" of two complex drug substances under the orphan drug regulation for establishing exclusivity.
Furthermore, unlike other drugs that are synthesized chemically, many complex substances require documentation and validation studies on the biological identity and purity of the naturally occurring or genetically engineered source materials. Manufacturers must show the absence of contamination by viruses and other human pathogens including the bovine spongiform encephalopathy agent.
In order to address all the issues surrounding complex drug substances, the committee has been formed with multi-disciplinary members from the different centers in FDA. The committee also provides oversight for CDER members serving on the intercenter working groups for transgenic plants and the International Conference on Harmonization document on biotechnology products. There are three technical subcommittees and seven working groups involved with guidances, issues and topics concerning complex drug substances, excipients and reagents.
The technical subcommittees deal with proteins used as active ingredients and reagents, excipients (liposomes and cyclodextrins) and synthetic peptides. The working groups handle cell metabolites derived from genetically engineered cells, natural and synthetic conjugated estrogens, botanical drugs, bovine spongiform encephalopathy, antibiotic fermentation, synthetic oligonucleotides and comparability protocols.
Many documents for policies and scientific standards have been drafted or are under development by the technical subcommittees and working groups. Conjugated estrogen products provide an excellent example to illustrate the complicated issues facing the committee and its accomplishments.
The committee has drafted and forwarded to the U.S. Pharmacopoeia for its review and adoption monographs on natural conjugated estrogen drug substance, synthetic conjugated estrogen drug substances and synthetic conjugated estrogen drug products.
The committee recently issued a draft guidance for industry on a method suitable for characterizing the more than 100 components present in natural conjugated estrogens. Another draft guidance on chemical characterization, documentation of pharmaceutical equivalence, bioavailability and bioequivalence of natural conjugated estrogen is close to being finalized.
These three different documents for natural conjugated estrogen have been written partially based on the analytical method developed by CDER's laboratory and the results of their analytical studies performed on Premarin.
Availability of generic products containing synthetic conjugated estrogens and, more importantly, natural conjugated estrogens will be possible when the monographs and guidances are finalized and followed by drug sponsors and applicants.
Mei-Ling Chen and Yuan-yuan Chiu are co-chairs of the CDSCC.
Some typical examples of complex drug substances are:
Chemically, these complex substances can be peptides, proteins, oligonucleotides, oligo- and polysaccharides, lipids and phospholipids and conjugates of conventional drugs with macromolecules such as monoclonal antibodies.
They can also be mixtures of naturally derived small molecules such as steroids and plant sterols.
Finally, they can be cell metabolites such as antibiotics, amino acids and vitamins produced by recombinant DNA technology.
By Kofi Kumi, Ph.D., Emmanuel Fadiran, Ph.D., Lydia Kieffer, Pharm.D., and Larry Lesko, Ph.D.
Regulatory scientists within the Office of Clinical Pharmacology and Biopharmaceutics held their eighth science day March 13. The keynote speaker was William J. Jusko, Ph.D., professor of pharmaceutics, State University of New York at Buffalo. Dr. Jusko is a world-renowned scientist who specializes in clinical, basic and theoretical pharmacokinetics and pharmacodynamics of diverse drugs, particularly corticosteroids and immunosuppressants.
Dr Jusko's presentation was entitled "The Role of PK/PD Modeling in Drug Development." Dr. Jusko discussed the purpose of PK/PD modeling and the components of models. He gave examples of models and used a case study to illustrate the utility of modeling in drug development. The goals of modeling, he said, are to codify current facts, test competing hypotheses, predict system response under new conditions and estimate inaccessible system variables.
Pharmacokinetics (PK) describes the action of drugs in the body over a period of time, including their absorption, distribution, localization in tissues, biotransformation and excretion.
Pharmacodynamics (PD) is the study of the biochemical and physiological effects of drugs and the mechanisms of their actions.
He used an information flow diagram to illustrate how PK/PD affects drug discover, preclinical studies, clinical trials and regulatory decision making. He illustrated how PK/PD was involved in the development of a benzodiazepine antianxiety agent and the immunosuppressant drug tacrolimus.
Dr. Jusko concluded by noting that diverse mechanisms and processes control drug effects. There are a variety of mechanism-based models available for handling experimental data. PK/PD models allow rational use and coupling of in vitro, animal and human data for quantification and prediction of drug responses.
Brian Booth, Ph.D., started the day's podium presentations with an update on a proposed guidance on analytical methods validation. Technical progress within the past decade has required additions to the proposed guidance, first issued as a report in 1992. He provided an update on a January workshop held to develop a consensus statement regarding bioanalytical method validation. The workshop was co-sponsored by the Association for the Advancement of Pharmaceutical Science and FDA. The consensus statement from the meeting is expected to assist in the preparation of the final version of the guidance.
Joette Meyer, Pharm.D., was the initial speaker in a series of presentations on PK/PD relationships in drug development. Dr. Meyer's presentation, "A comparative analysis of the concentration-effect relationship for two antibiotics in establishing cardiac safety," discussed a new antibiotic submitted for approval that was found to prolong the QT-interval of the electrocardiogram during development and another drug of same class also known to prolong the QT-interval.
The use of QT-interval data can establish a concentration-effect relationship for a drug and can be useful in comparing the safety of two related antibiotics. Since the concentration-effect response was similar for both drugs, Dr. Meyer concluded that data from the time of the new drug's actual maximum concentration demonstrated an improved correlation with effect compared to an analysis using a fixed time point.
Sam Haidar, Ph.D., pointed out some important shortcomings discovered in recent submissions in his talk, "Factors to consider in the design of PK/PD studies using QTc prolongation as a PD endpoint."
Some of the shortcomings involved using incorrect subjects and giving doses lower than the marketed doses, which resulted in erroneous conclusions between QTc prolongation and dose or drug concentration. Other studies failed to appropriately characterize baseline values of the QTc interval.
Elena Mishina, Ph.D., presented a talk entitled "Population PK/PD model for nitroglycerin as a supportive evidence in the approval of a new formulation." The objective of the talk was to establish a PK/PD model for comparing the pharmacodynamic effects of a newly developed nitroglycerin product and the marketed formulation.
The PD end-points were real time systolic-diastolic blood pressure ratio and the ratio of the pulse pressure value to the diastolic portion of the blood pressure waveform value. The results showed that the newly developed compressed tablets and the currently marketed reference tablet produced similar effects on peripheral vasodilatation when measured in the finger.
Dr. Mishina concluded that although the new formulation has not met the bioequivalence criteria with respect to Cmax of nitorglycerin, this inequivalence in plasma concentration did not seem to result in clinically significant differences in the PD effect.
Joga Gobburu, Ph.D., gave a presentation entitled "Chrono-Pharmacological Modeling of Ambulatory Blood Pressure Monitoring Data." The objective of Dr. Gobburu's work was to develop a nonlinear, mixed-effect model that describes the treatment effects of placebo and the antihypertensive drug diltiazem in patients with moderate to severe hypertension. The observed plasma concentrations were correlated with blood pressure measurements using a dual-cosine function for the placebo effect and a linear model for the treatment effect. Nonlinear, mixed-effects modeling was performed.
The contribution of age, body weight, race and gender in explaining the inter-individual variability was tested. The modeling exercise indicated that the asymmetric pattern in the circadian rhythm in blood pressure could be modeled using the sum of two cosine functions. None of the covariates tested showed significant influence on the model parameters.
Dr. Gobburu concluded that a correlation between diltiazem concentration and blood pressure was established. This relationship helped to better appreciate the effect of biorhythm on blood pressure and the shallow nature of the effect.
In "PK/PD modeling as a legal aid: Diltiazem's twin-peak citizen's petition," Patrick Marroum, Ph.D. illustrated how PK/PD was used to support a regulatory decision regarding a citizen's petition requesting that a generic version of diltiazem not be approved because it failed to exhibit the same concentration and dissolution profile as the original product with regard to a second peak in plasma.
The relationship between plasma diltiazem concentration and blood pressure could be explained by a linear pharmacodynamic model. The concentration-effect, based on the model, appears to be shallow. Large changes in concentration elicit small changes in pharmacodynamics.
Dr. Marroum concluded that based on the predictions of the model, the Agency was able to argue that a second peak in plasma concentration, when present, is not clinically necessary for maintaining adequate blood pressure lowering effect over the dosing interval and is not controllable in terms of the formulation's delivery of drug to the plasma.
The 14 poster presentations, including one from the Office of Generic Drugs by Pradeep Sathe, Ph.D., were:
The top three podium prizes went to Drs Gobburu, Marroum and Haidar in order. Drs Ibrahim and Zheng shared the first and second poster presentation prizes, and the third prize went to Drs. Reynolds and Chatterjee.
The next science day in October will feature regulatory scientists invited from Canada, Europe and Japan.
Abstracts are available on OCPB's intranet site at http://cdernet/ocpb/PRESMAIN.HTM.
All the authors are members of OCPB, and Dr. Lesko is OCPB Director.
By Tony Chite
1. Excessive growth of the male breast is:
a. gynocomastia b. gynecomastia c. gynecomostia d. gynecomastio
2. A doctor trained in the diseases and other disorders of domestic animals is a:
a. veterinarian b. vetrinarian c. vetrenarian d. veteranarian
3. When one drug is joined with another in therapy it is said to be:
a. concommitant b. concomittant c. concommittant d. concomitant
4. A space devoid of air or other gases is a:
a. vaccuum b. vaccum c. vacuum d. vaccume
5. An abnormal frequency and liquidity of fecal discharges is:
a. diarrhea b. diarhhea c. diarrhhea d. diaorhhea
6. A place for serving meals to the public is a:
a. resteraunt b. restaurant c. restaraunt d. restoraunt
7. To disable or to deprive of strength or ability is to:
a. incapacitate b. incopacitate c. incapacotate d. incapasitate
8. That which is absolutely required is:
a. nesessary b. necessary c. nessecary d. neccessary
9. An exact copy as of a document is a:
a. fascimile b. facisimile c. facsimile d. facsemile
10. A form of dislocation in which there is separation of two bones normally attached to each other without the existence of a true joint is:
a. diastasis b. diasstasis c. diastassis d. diastisis
Answers to the spelling quiz:
1b; 2a; 3d; 4c; 5a; 6b; 7a; 8b; 9c; 10a
Tony Chite is a consumer safety officer in CDER's Freedom of Information Division.
The Division of Training and Development's Reviewer Education Team develops and coordinates a broad range of educational programs for CDER's staff. The team's overall goal is to provide all employees involved in the drug review process with the tools they need to perform quality and timely reviews, ensuring the approval of safe and effective medicines for the American public.
These tools range from basic information about drug regulations, ethics rules, freedom of information and protecting proprietary data to advanced information needed for complex regulatory issues.
The team has developed and currently manages four broad training programs to meet the educational needs of CDER's review staff, non-review staff and support staff. These four programs focus on general training, reviewers education and training, interpersonal skills for individuals and leadership and management development.
The General Training Program is offered to all CDER staff. New employees should take advantage of these programs within the first three months of joining the Center. Offerings include an orientation for new employees, time management and basic concepts in the drug review process for the non-reviewer.
The FDA Modernization Act mandated that each FDA center conduct training and education programs related to the regulatory responsibilities of new employees. Included in this general mandate is a specific reference to reviewer training, both basic and advanced.
The Reviewer Education Training Program provides reviewers with the skills needed to perform professional and timely drug reviews. Courses include workshops on issues for new reviewers, risk management, regulatory science, basic drug law and the regulatory review of investigational new drug applications.
In addition to critical scientific skills, our employees must communicate effectively with each other and their colleagues throughout FDA and with advisory committee members, industry representatives and with other external stakeholders.
The Interpersonal Skills Program provides training in basic presentation skills, conducting successful meetings and producing effective minutes.
In addition to technical skills, CDER's employees need to adapt to change through strong leadership and management skills. The Leadership and Management Development Program develops the Center's managers and team leaders. The courses offered are an eclectic mix of internal and external development opportunities and include the essentials of team leadership, an introduction to supervision and the CDER Leadership Development Program.
The team also coordinates and schedules the Technical Writing Program, a comprehensive series of courses designed to improve the overall capabilities of CDER staff in grammar, organization and basic writing style.
Additional courses provide instruction in managing the writing of others and in preparing to publish in a scientific or technical journal. Special sessions can be organized for senior CDER managers and personnel with individual writing challenges
The team manages a two-day training course to improve the communication skills of reviewers who present at advisory committee meetings.
The Reviewer Education Team's members are Janice Newcomb (acting team leader), Sonya Armstrong, Dee Rhodes, Charlotte Henning, Debra Rose, Cheryl Kaiser, Noreen Gomez and Jim Mintner.
If you have questions about the reviewer education programs, contact Janice Newcomb (NEWCOMBJ, 7-4580).
Scientific Rounds in February, March and April featured presentations of investigations performed by Center scientists. The individual research projects were funded under the Center's Regulatory Science and Review Enhancement Program. The investigators and their projects were:
By Darek Maciasz
As a student in pharmacy school I had spent several years pounding out exam after exam, not realizing that I would soon have to pick out my three "practice sites." Practice sites provide different settings for students to apply what they have learned. At my school, for example, we are required to choose a hospital and a retail setting, as well as an elective, which can be almost anything.
At first, I was overwhelmed by the number of practice sites available. Then, years of negative feedback in from individuals who tried to make me believe that, after I graduated from pharmacy school I would have limited career opportunities. Being born and raised in Chicago, I was neither timid nor easily dissuaded.
With the deadline for picking practice sites approaching fast, I had chosen my hospital and retail sites. I had picked a clinical site for my elective, but I felt that my choices were too limited. To find more opportunities, I approached the dean of my college and the director of student practice sites. During a discussion I asked if they knew of a practice site that was different.
After brainstorming the idea for several months, the government came into focus. To my great surprise, I wasn't at all discouraged from pursuing this idea. In fact, it became a challenge for the three of us to locate a government rotation site. After seemingly endless phone calls and submissions of paperwork between the Agency and the school, I was fortunate enough to get accepted for a site with CDER's Drug Information Branch. At that moment, I felt proud to be an American because I would be helping my country to the best of my ability.
After the initial shock of the announcement set in, my immediate family and I faced a big reality check. What was I getting myself involved in? How expensive would it be. Would I survive the drive and being 13 hours away from the comforts of home. What would it be like to be part of an government institution that helps the whole U.S. population?
As many of these thoughts were at first overwhelming, others added to my anxiety by sharing their supposed insights on how the federal government worked. This constant badgering began to cloud my perspective. The mental strain that began to develop as time wore closer to my arrival at the FDA was nerve-racking. I began to think: Would I be able to fit in? Could I be successful in my rotation? Would I be able to learn all that there is to be offered by the government? Is it seriously true what people have said?
A lot of individuals back home had told me the people I would meet would be very snobbish and that if you don't fit in with the crowd I would be outcast. Well, don't believe everything people tell you.
I arrived in Maryland on Saturday, April 15, to begin my rotation on Monday. Great, I had two days to relax and familiarize myself with the area. On Sunday, I practiced the drive from where I was staying to FDA. Let me tell you, driving Interstate 495 is no problem on a Sunday. Driving on Monday morning was a nightmare. I thought the Kennedy in Chicago was bad, but this was just crazy. People have to drive 495 every day. No wonder they go crazy!
When I entered the Parklawn Building that first day, I was impressed and felt timid. All the governmental employees I met were sincere and willing to help. I was amazed at the people that work here. People back home had told me that I would just be a workhorse and that I wouldn't see or meet anybody since I'd be stuck working behind a desk all day. They were wrong.
My preceptors at the Drug Information Branch helped me really get a better understanding of the structure of FDA. They showed me how the drug approval process works from the inside and didn't just provide a textbook overview. They helped me in addressing issues when answering questions from members of the public by returning e-mails and phone calls. Yes, I did have to work, but I learned. It was easy to overlook the inconvenience of getting to work, because this was such a great opportunity. It was a great place to meet future healthcare professionals and people who will have a great impact on the public health of all Americans.
It was a feeling of freedom to have an opportunity to learn how I can be a part of and help my fellow Americans. We have the freedom to pursue what we want in life. If there is a barrier in the road you are traveling, find a different path, go around it, fly over it or dig a tunnel underneath it. I am grateful that my alma mater, the Chicago College of Pharmacy is open-minded and a true creator of freedom.
Darek Maciasz participated in the month-long pharmacy student mentoring program operated by the Drug Information Branch. The program enhances the Center's consumer education efforts. For more information, contact Barry Poole (7-3454, POOLEB).
Back in the dark ages when I took an introductory psychology course, I learned more than I cared to know about how rats press levers and run mazes. It turns out that I had learned even less than I thought I had learned and carried around a serious misconception for more than two decades. What I actually learned was how male rats press levers and run mazes.
At the time, one of the bright proto-feminists in my study group asked: "Why are all these experiments done with male rats?"
The graduate assistant imperiously told us: "Whenever we run an experiment, we try to control as many variable as we can. Because female hormones cycle, they add an uncontrolled variable."
I soon forgot most of what I learned in that course, but the message about male and female subjects in experiments lay undisturbed and unchallenged until I began working for HHS. The first scientist to disabuse me of my misconceptions was Patricia Grady, R.N., Ph.D., now head of NIH's National Institute of Nursing Research. She explained how the past pervasiveness of those misconceptions had created large gaps in our knowledge about women's health and how to treat and prevent illness in half the population.
So, it was with the notion that I may have many misconceptions that need reappraisal that I accepted an invitation from Jonca Bull, M.D., to learn more about the FDA's Office of Women's Health and share it with you. Dr. Bull, the acting director, explained OWH is more than a source of grants for Center scientists. Founded in 1994, the office is the focal point within the Agency for women's health issues in regulatory science and in the Agency's outreach to women consumers.
I learned that the office is much more than intramural research grants and has a great deal of experience in outreach to nontraditional stakeholders. Marsha Henderson, who is in charge of the outreach program, that in its three and a half years of operation the "Take Time to Care" campaign has reach 6.5 million women. The program has leveraged the resources of national non-profit organizations, business, associations and women's and ethnic groups to deliver an urgent message to women nationwide: "Use Medicines Wisely." The program makes use of a colorful and compact brochure with tips for taking medicines and a record card for tracking medicine use. The program recently received a prestigious HHS Secretary's Award.
The Gender Effects Scientific Council, co-chaired by Dr. Bull and CDER's Sandy Kweder, M.D., addresses scientific and policy issues related to gender-specific responses to products. The council is responsible for policies regarding women in clinical trials, provides a forum for advocacy of women's health issues within the Agency and gives advice to conference and seminar organizers seeking FDA experts on women's health issues.
The scientific research program began in 1994 and is managed by Margaret Miller, Ph.D. The program funds intramural research projects aimed at improving the Agency's policies and decisions on women's health issues. Over the past six years, it was funded about 90 high-priority women's health projects with more than $8 million in grants.
Projects included basic and clinical research on autoimmune disease, cancer, cardiovascular disease, contraceptives, developmental and reproductive toxicology, gender differences, sexually transmitted infections, osteoporosis and pregnancy. The program has also funded several projects designed to examine gender differences in adverse events.
Other members of the office are Kennerly Chapman, project officer, and Patti Bradfield and Deborah Douglas, administrative staff. Take a moment to check out their newly redesigned Web site at http://www.fda.gov/womens.
The Pike is published electronically on the X:drive in Cdernews and on the World Wide Web at:
http://www.fda.gov/cder/pike.htm
Photocopies are available in the Medical Library (Parklawn Room 11B-40) and its branches (Corporate Boulevard Room S-121 and Woodmont II Room 3001).
Views and opinions expressed are those of the authors and do not necessarily reflect official FDA or CDER policies. All material in the Pike is in the public domain and may be freely copied or printed.
Celeste Bové
Charlene Cherry
Rose Cunningham
Bonnie Dunn
Pam Fagelson
Elaine Frost
Timothy Mahoney
Edward Miracco
Melissa Moncavage
Jim Morrison
Ellen Shapiro
Ted Sherwood
Tony Sims
Nancy Smith
Wendy Stanfield
Gloria Sundaresan
Marcia Trenter
Diane Walker
Grant Williams
Pamela Winbourne
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