FDA Related News

FDA General

Possible Agenda for Scott Gottlieb as FDA Boss

Endpoints News lists a number of items that Scott Gottlieb might pursue in his first six months if he was named FDA commissioner.

Intended Use at Root of FDA 1st Amendment Issues: Attorney

Attorney Jeffrey Shapiro says it isnt known what the Trump administration will do with FDAs controversial intended use final rule that is now schedule...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that cites Fenwal Inc. and Humco Holding Group.

Federal Register

Docket Established for Pediatric Postmarketing Reviews

Federal Register Notice: FDA has established a public docket to collect comments related to pediatric postmarketing pharmacovigilance and drug utiliza...

Human Drugs

New Patent Dance Suit Filed Over Avastin

Genentech asks a court to declare that Amgen is violating BPCIA patent dance provisions by failing to provide additional manufacturing information in ...

Human Drugs

Multiple Violations at Humco Holding Group

FDAs Dallas District Office warns Humco Holdings about CGMP and other violations in its manufacturing of finished pharmaceuticals.

Human Drugs

Momenta Glatopa Fill/Finish Contractor Warned

Momenta says approval of its ANDA for Glatopa 40 mg will likely be delayed due to an FDA Warning Letter issued to a contract Pfizer fill/finish facili...

Securities Suits Continue Against Life Sciences Companies: Attorneys

Four Dechert attorneys write in a white paper that life sciences companies remain an easy target for securities class action lawsuits and should take ...

Human Drugs

Petition Asks Potassium Chloride Actions

Vertice asks FDA to require elemental metals testing and controls in any NDA or ANDA for potassium chloride oral drug products.

Biologics

FDA Priority Review for Pfizer Leukemia BLA

FDA accepts for priority review a Pfizer BLA for inotuzumab ozogamicin for treating adult patients with relapsed or refractory B-cell precursor acute ...