Regulatory Affairs Professionals Society

This Week at FDA: Makary reflects on first year, FDA working to lift peptide restrictions, 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

Commenters seek clarity, expansion of multiple myeloma accelerated approval draft guidance

Stakeholders responding to recent draft guidance from the US Food and Drug Administration (FDA) on the use of minimal ...
RAPS

Regulatory Focus™

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...
RAPS

Regulatory Focus™

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, ...