FDA Related News

FDA Denies Nitric Oxide Petition

FDA denies two of three requests from a petition challenging the clearance and approval of certain nitric oxide products.

Medical Devices

Alaris Hardware Recall Class 1, 2

FDA says three of four problem scenarios described by Becton Dickinson in its recall of Alaris infusion pumps are Class 1.

Human Drugs

Trump Claims Pricing Meeting with Drug Companies

President Trump says drug company executives are coming to see him this week and he expects a major cut in prescription drug prices.

Human Drugs

CGMP Issues at Mylan Sangareddy Plant

FDA warns Mylan about CGMP deviations in producing active pharmaceutical ingredients at one of its facilities in India.

Human Drugs

CGMP, Other Violations at Acella Pharmaceuticals

FDA warns Acella Pharmaceuticals about CGMP and other violations in its production of finished drugs.

Human Drugs

2 Stakeholders Responses on Orange Book Q&A

Two drug company stakeholders respond to an FDA draft guidance on Orange Book questions and answers.

Medical Devices

Reasons HHS Decision on Lab Tests Was Good: Attorney

Attorney Jeffrey Shapiro discusses reasons why HHS made the right decision in ordering FDA to abstain from the premarket review of laboratory-develope...

FDA General

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes Acella Pharmaceuticals, Mylan and Revival Products.

Combination Product Review Practices Work Well: Report

An assessment finds that combination product review practices are generally efficient and effective and need only minor adjustments.

Human Drugs

Indivior Exec Pleads Guilty in Suboxone Film Case

The Justice Department says the former Indivior global medical director has pleaded guilty to a single misdemeanor charge of introducing misbranded Su...