FDA Related News

Federal Register

FDA Withdrawing Watson Labs Oxycodone Hydrochloride

Federal Register notice: FDA proposes to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen tablets and is anno...

Federal Register

FDA Withdrawing InvaGen Trandolapril ANDA

Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets.

FDA Regenerative Medicine Framework is Important Step: Pew

A Pew Charitable Trusts report praises the FDA 2017 framework on regulation of regenerative medicine as a good first step and says much more needs to ...

Human Drugs

Court Rejects Innovator Liability in Generic Drug Case

Washington Legal Foundation reports on an Idaho state court decision that rejected the legal theory that a branded drug company can be held liable for...

Human Drugs

Continuous Pharmaceutical Manufacturing Bill In

Reps. Pallone and Guthrie introduce bipartisan legislation to allow FDA to partner with universities as National Centers of Excellence in Continuous P...

FDA General

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes one medical product company PetNet Solutions.

Medical Devices

HeartVista AI-assisted MRI Software Cleared

FDA clears a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams.

Human Drugs

PET Drug CGMP Issues at Petnet

FDA warns Petnet Solutions about CGMP violations in its manufacturing of positron emission tomography drugs.

Federal Register

National Center for Toxicological Research Panel Meeting 12/3-4

Federal Register notice: FDA announces a 12/3-4 Science Advisory Board to the National Center for Toxicological Research advisory committee meeting.

Federal Register

Class 1 for Continuous Glucose Monitor Data Systems

Federal Register notice: FDA classifies continuous glucose monitor data management systems into Class 1 (general controls).