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Center for Drug Evaluation and Research, U.S. Food and Drug Administration - CDER/FDA Organization URL(s) www.fda.gov/cder/ Other Contact Information 5600 Fishers Lane Rockville, MD 20857 301-827-4573 (Voice, Drug Information) 301-827-4577 (FAX) Description The CDER Executive Secretariat Staff (CESS), Center for Drug Evaluation and Research, responds to written consumer, health professional, professional organization, government agency, etc., inquiries covering the entire spectrum of prescription (Rx) and over-the-counter (OTC) drug issues. CESS develops Center and agency responses to drug information requests under the provision of Food and Drug Administration's (FDA's) procedural regulations and established policies. CESS prepares, maintains, and provides health and drug information/education printed materials to the public, the health care industry, Congress, foreign dignitaries, etc. Inquiries are received by fax or mail; however, all Freedom of Information requests should be sent via written correspondence to the Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Online Resources About CDER (Center for Drug Evaluation and Research/FDA) http://www.fda.gov/cder/about/default.htm Approved Drug Products with Therapeutic Equivalence Evaluations http://www.fda.gov/cder/orange/adp.htm Buying Prescription Medicines Online: A Consumer Safety Guide http://www.fda.gov/cder/consumerinfo/buyOnlineGuide.htm Celebrex http://www.fda.gov/cder/consumerinfo/druginfo/celebrex.htm Consumer Drug Information Page - Center for Drug Evaluation and Research http://www.fda.gov/cder/consumerinfo/default.htm Doxycycline and Penicillin G Procaine for Inhalational Anthrax (Post-Exposure) http://www.fda.gov/cder/drug/infopage/penG_doxy/default.htm Drug Information Home Page - Center for Drug Evaluation and Research http://www.fda.gov/cder/drug/default.htm Drugs at FDA http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women http://www.fda.gov/cder/drug/infopage/estrogens_progestins/default.htm FAQ - About Thalidomide http://www.fda.gov/cder/news/thalinfo/thalfaq.htm FAQ - About Viagra http://www.fda.gov/cder/consumerinfo/viagra/viagrafaq.htm FAQ--Cipro (Ciprofloxacin Hydrochloride) for Inhalation Anthrax http://www.fda.gov/cder/drug/infopage/cipro/cipro_faq.htm Frequently Asked Questions on Potassium Iodide (KI) http://www.fda.gov/cder/drugprepare/KI_Q&A.htm; Generic Drugs: Questions and Answers http://www.fda.gov/cder/consumerinfo/generics_q&a.htm; Got a Sick Kid? Don’t Guess. Read the Label. http://www.fda.gov/cder/consumerinfo/sickkids.htm Influenza Antiviral Drugs and Related Information http://www.fda.gov/cder/drug/antivirals/influenza/default.htm Lotronex Information http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm Medication Errors http://www.fda.gov/cder/drug/mederrors/default.htm MedWatch, the U.S. Food and Drug Administration (FDA) Medical Products Reporting Program http://www.fda.gov/medwatch/index.html Mifepristone Information http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm Oncology Tools http://www.fda.gov/cder/cancer/ Over-the-Counter (OTC) Home Page http://www.fda.gov/cder/offices/otc/default.htm Over-the-Counter Drug Review Process http://www.fda.gov/cder/handbook/otcpage.htm Pediatric Drug Development/Best Pharmaceuticals for Children Act (BPCA) http://www.fda.gov/cder/pediatric/ Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies http://www.fda.gov/cder/guidance/4825fnl.htm Questions and Answers for Withdrawal of Duract http://www.fda.gov/cder/news/duract/qa.htm Thalidomide Information for Consumers http://www.fda.gov/cder/news/thalinfo/thalomid.htm Vioxx (rofecoxib) Questions and Answers http://www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm Warning Letters and Notice of Violation Letters to Pharmaceutical Companies http://www.fda.gov/cder/warn/index.htm Print Resources CESS publications include labeling for FDA approved prescription drugs, CESS Fact Sheets, CESS information packets, FDA Consumer magazine reprints, drug information brochures, FDA Backgrounders, FDA Talk Papers, and FDA Medical Bulletin. CESS regulatory publications include guidelines, information packets, and Federal Register notices relative to the drug approval process. Information and guidance to order other regulatory manuals, directories, or drug evaluation reports are also available. Related Topics Antibiotics Drug Labeling Drugs Federal Programs Food Safety Generic Drugs Ibuprofen Nonprescription Drugs Over-the-Counter Drugs Pharmaceuticals Product Safety Research Weight Control Drug Allergies Prescription Drugs Fen/Phen Drug Safety Medical Errors Bioterrorism Anthrax Review Date Wed Sep 15, 2004

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