FDA Related News

Medical Devices

iRhythm Hit with 483 After July Inspection

FDA issues iRhythm Technologies a Form FDA-483 after an inspection last month cited three GMP deficiencies.

Medical Devices

HHS Assists FDA with BDs Bactec Shortage

HHS says it is working with FDA to help resolve an ongoing supply shortage of BDs Bactec blood culture media bottles.

Human Drugs

Imfinzi OKd for Resectable Lung Cancer

AstraZeneca gains FDA approval for Imfinzi (durvalumab) with platinum-containing chemotherapy for adults with resectable non-small cell lung cancer.

Human Drugs

Court Nixes Restraining Order Request in Entresto Suit

The Washington DC District Court rejects a Novartis motion in a generic drug carve-out case for a preliminary injunction to stay FDAs approval of MSN ...

Federal Register

No-Longer-Marketed Enteregs Approval Withdrawn

Federal Register notice: FDA withdraws approval of Cubist Pharmaceuticals Entereg (alvimopan) capsules because it is no longer marketed.

Federal Register

Regulatory Review Period for B+Ls Miebo

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bausch + Lombs eye drug Miebo (perfluorohexyloc...

Federal Register

FDA Debars Ryan Stabile for 15 Years

Federal Register notice: FDA debars Ryan Stabile for 15 years from importing or offering for import any drug into the U.S.

More FDA Stringency Seen on Accelerated Drug OKs

Two Sheppard Mullin attorneys say sponsors of drugs approved through expedited pathways should learn from a recent FDA untitled letter faulting Mirais...

Medical Devices

FDA Clears Cresilons Traumagel

FDA clears Cresilons Traumagel device that uses a plant-based technology to control moderate to severe bleeding at the point of care.

Human Drugs

FDA Touts CDER Advanced Manufacturing Research Facility

FDA describes CDERs new state-of-the-art advanced manufacturing research facility.