FDA Related News

Biologics

2 Governors Ask FDA Vaccine Pooling Approval

Govs. Polis and Brown call on FDA to approve Covid vaccine pooling.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Evelyn Lopez-Brignoni and Cannafyl.

Human Drugs

Author Encouraged by Decade of FDA Drug Approvals

A review of FDA drug approvals in the last decade covers 378 novel drugs and 27 biosimilars, with 25% of them for oncology indications.

Human Drugs

Objectionable Clinical Trial Practices at Florida Clinic

FDA warns a Florida doctor about objectionable conditions in the practices conduct of two clinical trials.

Cannafyl Marketing Unapproved Human, Animal CBD Drugs

FDA warns Cannafyl it is marketing unapproved and misbranded new drugs for use in humans and an unapproved new animal drug.

Human Drugs

FDA Tells Acadia that Nuplazid sNDA has Deficiencies

FDA tells Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating hallucinations and ...

Medical Devices

FDA Issues Section 506J Notification Obligation Table

FDA issues a table with recommendations for medical device manufacturers to use in association with an earlier pandemic guidance on notifying the agen...

Human Drugs

Sandoz Sues FDA Over Aubagio NCE Status

Sandoz asks the DC federal court to order FDA to set aside its award of new chemical entity status and exclusivity to Sanofi Genzymes Aubagio and to a...

Human Drugs

Generic Drug Correspondence Guidance Inadequate: AAM

The Association for Accessible Medicines raises several concerns with an FDA final guidance on controlled correspondence related to generic drug-devic...

Medical Devices

Brain Scientifics NeuroCap Cleared

FDA clears a Brain Scientific 510(k) for its NeuroCap device, an advanced electroencephalogram electrode array used to obtain rapid EEGs in routine cl...