Trump Proposes to Remove ‘Gender’ References in FDA Regulations

The Food and Drug Administration proposed Tuesday changing its regulations to remove references to gender in order to align ...
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 ...
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
JD Supra

FDA Food Chemical Regulation After the MAHA Executive Order

Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...
JD Supra

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed ...
Regulatory Affairs Professionals Society

This Week at FDA: FDA names acting CBER director, House committee advances FDA budget bill, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Agri-Pulse

FDA will consider tightening regulation of food additives

Robert F. Kennedy Jr. speaks at his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions. (Photo: Lydia Johnson) The Food and Drug Administration will consider ...
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 ...
WISH-TV

Morning Checkup | FDA could ease regulations on peptides

The FDA is considering easing restrictions on injectable peptides, raising concerns about safety and efficacy of untested ...
MD&M East

Embrace FDA Regulations: Turn Medtech Compliance Into Your Competitive Edge

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (ONLINE EVENT: Sept 14th ...

Growing opportunities in drug/device combinations are driven by the increased convergence of novel technologies and the merging of cell therapies with medicine and devices. Understanding EU and FDA ...