Fierce Pharma

FDA expectations create potential friction in new Form 483 response guidance

Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...

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 ...

FDA announces its first approval of fruit-flavored e-cigarettes for adults in major shift under Trump

The Food and Drug Administration on Tuesday announced its first authorization of fruit-flavored electronic cigarettes ...
The American Journal of Managed Care

FDA Draft Guidance Proposes CR, MRD to Accelerate MM Drug Approval

The FDA draft guidance recommends MRD and CR as endpoints for accelerated drug approval in multiple myeloma, emphasizing their role in indicating deep treatment response. MRD negativity is defined as ...
Regulatory Affairs Professionals Society

FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for antibiotics produced through fermentation or semi-synthetic methods.
Commercial Carrier Journal

FDA proposes rule to fast-track oral fluid and hair drug testing

Chris Spear and the ATA welcome an FDA rule change that targets drug test "cheating" by implementing oral fluid and hair ...
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 ...
Hosted on MSN

FDA advances AI and digital health guidance amid compliance push

The FDA is preparing 2026 guidance on artificial intelligence in drug manufacturing and digital health technologies in clinical trials to align innovation with strict compliance requirements. Industry ...
RAPS

FDA's proprietary name guidance seeks to avoid medication errors

The US Food and Drug Administration (FDA) has issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs. The best ...
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 ...