10.16.2020

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.
10.15.2020

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.
10.15.2020

Alexion snares OK for quicker-infusing Ultomiris formula—and a subQ version is on the horizon

Alexion snares OK for quicker-infusing Ultomiris formula—and a subQ version is on the horizon fkansteiner Thu, 10/15/2020 - 18:17
10.15.2020

Drug Master File (DMF) and Drug Substance Workshop - 03/03/2021 - 03/04/2021

Drug Master File (DMF) and Drug Substance Workshop
10.15.2020

2020 Drug Safety Communications

2020 Drug Safety Communications
10.15.2020

Drug Safety Communications

FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories issued prior to January 29th, 2010.
10.15.2020

Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling

Clinical Pharmacology
10.15.2020

Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea - 10/27/2020 - 10/27/2020

The purpose of the public virtual workshop is to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea.
10.15.2020

Berkeley Nutritional Mfg Corp. - 500324 - 01/31/2017

CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
10.15.2020

Endocrinologic and Metabolic Drugs Advisory Committee Roster

Advisory Committees (Drugs)