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Center for Drug Evaluation and Research

Apr 16, 2020
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
Apr 01, 2020
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
Mar 31, 2020
Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19
Mar 10, 2020
FDA Inks Research Collaboration Agreement with AnaBios Focused on Human Primary Cardiomyocytes
Mar 09, 2020
FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications
Mar 04, 2020
FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast
Mar 04, 2020
FDAnews Announces -- Drug Shortages and cGMP/Quality: An Interview with CDER Deputy Director Dr. Douglas C. Throckmorton Webinar, Mar. 18, 2020
Dec 20, 2019
The Patients as Partners US Conference Announces 2020 Keynotes
Dec 19, 2019
FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence
Nov 14, 2019
FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs
Nov 05, 2019
FDA's CDER Dir. Janet Woodcock and Johns Hopkins Researcher Thomas Stanton to Headline 2019 PDA Quality Week
Nov 01, 2019
Statement from Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research on new testing results, including low levels of impurities in ranitidine drugs
Sep 24, 2019
FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
Sep 13, 2019
Statement from FDA's Center for Drug Evaluation and Research Director Janet Woodcock, M.D., alerting patients and health care professionals of NDMA found in samples of ranitidine
Sep 05, 2019
CASI Pharmaceuticals, Inc. to Host Key Opinion Leader Symposium on September 10, 2019 in New York City
Aug 28, 2019
Veterinary Drug Approval Process and FDA Regulatory Course: Chicago, IL, United States - December 5-6, 2019
Aug 28, 2019
Two Day Veterinary Drug Approval Process and FDA Regulatory Oversight Seminar: Kansas City, United States - September 26-27, 2019
Aug 27, 2019
FDA requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks
Aug 06, 2019
FDA statement on court ruling related to compounded bulk drug substances and the agency's ongoing efforts to implement its compounding authorities
May 29, 2019
Former FDA Associate Director, Office of Epidemiology & Biostatistics (CDER), William Fairweather, PhD, PSTAT, Joins NDA Partners
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