FDA Related News

Human Drugs

FDA Refusal to File Wakix sNDA

FDA refuses to file a Harmony Biosciences Wakix sNDA to treat excessive daytime sleepiness due to idiopathic hypersomnia.

Human Drugs

AGs Seek FDA Actions on Counterfeit GLP-1 Drugs

A bipartisan coalition of 37 state Attorneys General call on FDA to take enforcement actions against online sellers of counterfeit versions of popular...

Human Drugs

Disappointing Data on Supernus Depression Drug

Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a statistically signific...

Human Drugs

Expanded Access to TICE BCG Substitute

FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.

What Happens to FDA in a Budget Shutdown?

Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2019 government shutd...

FDA General

AdvaMed Urges HHS Reversal of FDA Staff Cuts

Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.

2024 Device Recalls Up, Drug Recalls Down: Sedgwick

The Sedgwick full-year recall report for 2024 shows medical device recalls increasing and drug recalls decreasing.

Medical Devices

Becton Dickinson Recalls ChloraPrep Lot

Becton Dickinson recalls one lot of ChloraPrep clear 1 mL applicators due to fungal contamination concerns.

Human Drugs

Multiple Violations at Jagsonpal Pharmaceuticals

FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutical ingredients.

Human Drugs

CGMP Deviations at Tyche Industries

FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.