FDA Related News

Human Drugs

FDA Approves New Erbitux Dosing Regimen

FDA approves a new dosage regimen 120-minute intravenous infusion every two weeks for Imclones Erbitux (cetuximab) for treating patients with K-Ras ...

Human Drugs

Qmart Recalls Products with Undeclared Ingredients

Qmart recalls all lots of its Imperial Gold 2000, PremierZen Extreme 3000, Burro en Primavera 60000 and Imperial Platinum 2000 after an FDA analysis f...

Human Drugs

FDA Advisors to Review FibroGen Roxadustat NDA

In preparation for a 7/15 FDA advisory committee meeting to consider a FibroGen NDA for roxadustat, the company clarifies some of its trial data invol...

Human Drugs

Curex Marketing Unapproved Allergy Drops: FDA

CBER cautions Curex, Inc., New York, NY, that it is unlawfully marketing and distributing allergy drops and drop compounds.

Human Drugs

RPK Drug Cream Label Doesnt Match Listed Drug Name: FDA

FDA warns RPK Pharmaceuticals about a listing discrepancy for a drug cream it manufactures.

Medical Devices

Part of Whistleblower Medtronic Spinal Device Suit Can Proceed: 9th Circuit

The 9th Circuit Court of Appeals reverses part of a California federal court decision that dismissed all whistleblower claims against Medtronic over t...

FDA General

No Movement on Nominating FDA Commissioner

The Biden Administration shows no signs of moving to nominate an FDA commissioner, which could leave current acting commissioner Janet Woodcock at the...

Human Drugs

7 Observations in Wells Pharmacy Inspection

FDA releases the FDA-483 issued following an inspection at the Wells Pharmacy, Dyersburg, TN, outsourcing facility.

FDA Continues to Act on CBD Health Claims: Attorneys

Troutman Pepper attorneys say FDA is continuing action against companies claiming health benefits for CBD products.

FDA General

Cooley Hires Ex-FDA Lawyer Nath

Former FDA lawyer Sonia Wadhwa Nath joins Cooley as a partner in the law firms business litigation and healthcare regulatory practice groups based in ...