FDA Related News

FDA General

Industry Defense Shows FDA is Politically Impaired: Column

Two NYU medical school professors say it shows how wounded FDA is politically when drug companies feel a need to reassure the public that they wont di...

62% of Americans Fear Vaccine Political Pressure: Poll

The September Kaiser Family Foundation health tracking poll shows that many people fear that political pressure will force FDA to rush approval of a C...

Biologics

Janssen sBLA for Darzalex FasPro for Amyloidosis

Janssen Pharmaceutical Companies files a supplemental BLA for Darzalex FasPro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of dara...

Human Drugs

FDA Warns 17 Web Sites Illegally Selling Opioids

FDA warns 17 Web site operators that they are illegally selling unapproved and misbranded opioids.

8 FDA Execs Say Agency is Following the Science

The eight top FDA career executives write in a USA Today opinion piece that they are committed to following the science within the political environme...

Human Drugs

FDA Holds Up Sarepta Gene Therapy Trial

FDA trepidation with gene therapies continues as it holds up a Sarepta Therapeutics clinical trial by asking for an additional potency assay to releas...

Human Drugs

FDA Approves sNDA for GSKs Trelegy Ellipta

FDA approves a GlaxoSmithKline a supplemental NDA for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in patients ag...

Human Drugs

Return Drug Manufacturing to U.S.: Hahn, Shah

FDA commissioner Stephen Hahn and associate commissioner Anand Shah say its time for investments and incentives to be added to FDAs efforts to bring m...

Medical Devices

Minnetronix Medical MindsEye Expandable Port Cleared

FDA clears a Minnetronix Medical 510(k) for the MindsEye Expandable Port for neurosurgical procedures.

Federal Register

Corrected Federal Register Notice on Right to Try

Federal Register notice: FDA corrects a 7/24 notice on Annual Summary Reporting Requirements Under the Right to Try Act.