Clinical Trials Arena

FDA locks down post-approval pregnancy safety data framework

This FDA framework comes as significant knowledge gaps remain around the efficacy and safety of drugs in pregnancy and lactation.
Becker's Hospital Review

FDA issues guidance for safe drug use during pregnancy

The FDA has issued guidance outlining recommendations for studying the safety of drugs and biologics used during pregnancy ...
MiBolsilloColombia on MSN

Vapers avoided bans under new FDA guidelines

The FDA signaled it may delay enforcement against some unauthorized vape products while their marketing applications remain ...
Clinical Pain Advisor

FDA Guidance Addresses Drug Safety Evaluation in Pregnancy

The FDA issues additional guidance on how post-marketing data may be leveraged in relation to product safety and pregnancy-related risk.

FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics

“Pregnant women and their healthcare providers need clear, reliable information to make informed treatment decisions,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance supports better ...
Regulatory Affairs Professionals Society

This Week at FDA: Makary reportedly on the way out at FDA, new guidance, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Regulatory Affairs Professionals Society

FDA finalizes guidance on CMC flexibilities for cell and gene therapies

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
Hoodline

D.C. Vape Crackdown Blinks As FDA Gives Some Makers A Temporary Pass

Washington’s long-running war on vapes just shifted tactics. The Food and Drug Administration on May 8 rolled out new ...

FDA’s new playbook: Lots of media announcements but not much rulemaking

More than a year later, the FDA has not introduced any of the detailed, scientific regulatory documents needed to establish a ...
Hosted on MSN

FDA finalizes guidance to enhance pregnancy drug safety research

FDA guidance released: The agency urges manufacturers to use registries, real-world evidence, and case reports to strengthen safety data for drugs used during pregnancy. Blood sugar findings: ...