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 ...
Life Science Leader

A Door Ajar: FDA's Final SIUU Guidance And Off-Label Communications

FDA’s final SIUU guidance loosens some off-label communication rules, but drugmakers still face strict compliance demands to ...
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 ...

FDA Guidance Lifts Philip Morris Smoke Free Story And Valuation Debate

FDA issues new regulatory guidance that supports commercialization of Philip Morris International's ZYN Ultra and IQOS in the ...
Becker's Spine Review

FDA shares guidance on patient-matched orthopedic implants: 10 notes

The FDA finalized its guidance on patient-matched guides for orthopedic implants. These guides have become a familiar part of orthopedic and spine surgery, and the FDA’s May 7 document sets ...
KCCI Des Moines

FDA: COVID vaccines not recommended for most Americans

Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved ...

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

The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the ...
Infectious Disease Advisor

FDA Guidance Addresses Drug Safety Evaluation in Pregnancy

The FDA issued guidance aimed at improving the collection of safety data for drugs and biological products used during pregnancy.
Healio

FDA-identified uncertainties about new cancer drugs often omitted in journals, guidelines

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...