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Human Drugs

Court OKs FDA Injunction Against Grandmas Herbs

The Utah federal court approves a permanent injunction sought by FDA preventing Grandmas Herbs and its owners from marketing dietary supplements that ...

Medical Devices

FDA Denies Stryker Patient Transport Exemption

FDA denies a Stryker Medical petition seeking a premarket notification exemption for some powered patient transport devices.

Human Drugs

Bryant Ranch Recalls Mislabeled Methocarbamol

Bryant Ranch Prepack recalls one lot of methocarbamol 500mg tablets due to a mislabeling error.

Biologics

Senators Want More Covid Vaccine Data

Sens. Collins and Burr ask FDA and CDC to make more data available on Covid vaccine efficacy and breakthrough infections.

FDA General

FY 2021 Enforcement Stats Decimated by Covid

FDA updates its fiscal year (FY) 2021 FDA enforcement and compliance data, which show just how badly Covid-19 has decimated the agencys Warning Letter...

Medical Devices

Cook Medical Recalls Transseptal Needle

FDA says Cook Medical has recalled all unexpired lots of its transseptal needle and transseptal needle with catheter due to the presence of rust in or...

Biologics

FDA Allows More, Mixed Booster Vaccines

FDA authorizes Covid-19 vaccine booster doses for certain Moderna and Johnson & Johnson vaccinated individuals; it also authorizes available booster d...

Human Drugs

CGMP Violations at Sircle Laboratories

FDA warns Sircle Laboratories about CGMP violations in its production of finished drugs.

Human Drugs

Akero Gains Fast Track for NASH Drug

FDA grants Akero Therapeutics a fast track designation for efruxifermin and its use in treating non-alcoholic steatohepatitis (NASH).

Medical Devices

OTC Hearing Aid Proposed Rule Issued

FDA issues for comment a proposed rule and draft guidance on OTC hearing aids and personal sound amplification devices.