SILVER SPRING, Md., Sept. 19, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of September 19, 2011.
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FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
Events and Speeches for the Commissioner and FDA leadership:
Thursday, 9/22 FDA Commissioner Margaret A. Hamburg, M.D., participates in two-day symposium titled “Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials.”9 a.m., Thursday, 8 a.m., Friday; L’Enfrant Plaza Hotel, 480 L’Enfant Plaza, S.W., Washington, D.C.
Press Office Contact: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov
Meetings, Workshops and Congressional Testimony:
Monday, 9/19 2011 PDA/FDA Joint Regulatory Conference and TRI Courses. The FDA and Parenteral Drug Association cosponsor a three-day public conference beginning Monday to explore strategies for boosting development and improvement of safe and effective medical products. 7 a.m., Renaissance Hotel, 999 Ninth St., N.W., Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Tuesday, 9/20 Vaccines and Related Biological Products Advisory Committee Meeting. via teleconference in open session to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research. 1 p.m., National Institutes of Health Building, 29B/Conference Room C, Bethesda, Md.
Press Office Contact: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Thursday, 9/22 Start of two-day meeting of the Cellular, Tissue and Gene Therapies Advisory Committee.8 a.m., Hilton Washington D.C. North/Gaithersburg, 620 Perry Pkwy, Gaithersburg, Md.
Press Office Contact: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Thursday, 9/22 Opening day of a two-day meeting of the Pediatric Advisory Committee to consider influenza virus vaccines, the schizophrenia drug Abilify, and a joint study by FDA and the Agency for Healthcare Research and Quality on antipsychotic use and effects in children. Several drugs and their use in children will be discussed on the second day. 8 a.m., Hilton Washington D.C. North/Gaithersburg, 620 Perry Blvd., Gaithersburg, Md.
Press Office Contacts: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Monday, 9/26 Public Workshop: Center for Drug Evaluation and Research: Approach to Addressing Drug Shortages. The FDA workshop is intended to provide information for, and to gain insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, and others. 8:30 a.m., 10903 New Hampshire Ave., Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Monday, 9/26 Start of a two-day Tissue Adhesives/Soft Tissue Workshop on innovation and the appropriate regulatory pathways to develop new tissue adhesive biomaterials. 8 a.m., 10903 New Hampshire Ave., Building 2, Room A-2031, Silver Spring, Md.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
On the Web:
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
FDA Office of Public Affairs Contact Information:
Call or email FDA Office of Public Affairs, 301-796-4540, fdaopa@fda.hhs.gov
List of FDA press officers and beats
More Resources:
SOURCE U.S. Food and Drug Administration
