FDA Related News

Medical Devices

FDA Warns Doctor on Breast Augmentation Pocket

FDA warns a Beverly Hills, CA, doctor that his Pocket Protector used in breast augmentation procedures is an unapproved medical device that is being m...

Issues Raised on Proposed IRB Consent Waiver

Three stakeholder groups make recommendations on an FDA proposed rule on IRB waiver or alteration of informed consent for minimal risk clinical invest...

FDA General

9% Budget Boost for FDA, Biggest in Years

FDA receives a $269 million (9%) budget increase its biggest in recent years in a consensus appropriations bill signed into law by President Trump. ...

FDA OKs 1st Interoperable Insulin Pump

FDA allows marketing of Tandems interoperable t:Slim X2 insulin infusion pump, the first of its kind.

Human Drugs

Hill Seeks FDA Briefing on Blood Pressure Drug Recalls

House Energy and Commerce Committee leaders send a letter to FDA commissioner Scott Gottlieb requesting a briefing on numerous recalls involving drugs...

Human Drugs

Samson Pharmaceuticals Inspection Finds CGMP Issues

FDA warns Samson Pharmaceuticals about CGMP violations in its production of finished pharmaceuticals.

Federal Register

Regulatory Review Determined for Anacor Pharmas Eucrisa

Federal Register notice: FDA determines the regulatory review period for Anacor Pharmaceuticals Eucrisa (crisaborole), indicated for topical treatment...

Human Drugs

FDA Asked to Explain Dsuvia Approval

Sen. Markey and Rep. DeGette ask FDA for documents on various aspects of the agencys decision to approve AcelRx Dsuvia, a sublingual tablet form of su...

Human Drugs

Janssen Depression Drug Gains Joint Panel Backing

FDAs Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee vote 14 to 2 to support Janssen Pharmaceutical...

Human Drugs

Immunomedics FDA-483 Has 13 Observations

FDA releases an FDA-483 with 13 observations from a 2018 inspection at Immunomedics, a drug substance intermediary manufacturing facility.