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Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include American Global Health Products and Entia Biosciences.

FDA General

FDA Should Do More in Covid Response: GAO

The Government Accountability Office recommends additional things that FDA and other federal agencies should be doing as part of their response to the...

Medical Devices

Boston Scientific EMBLEM Electrode Recall is Class 1

FDA says a Boston Scientific recall of EMBLEM defibrillator electrodes due to potential fracturing is Class 1.

Medical Devices

FDA Clears Ventway Sparrow Ventilators

FDA clears an Inovytec 510(k) to market its Ventway Sparrow ventilators in the U.S.

Human Drugs

New FDA Rules on Inspection Records Requests

FDA sets up an interim process to communicate issues identified following a review of records or other information requested prior to or in lieu of a ...

Human Drugs

FDA Steps Up Efforts to Curb Illegal Opioids Online

An FDA pilot program removes almost 30 illegal Web sites that were offering opioids for sale.

Human Drugs

Concert Pharma Scraps Schizophrenia Drug

Concert Pharmaceuticals halts development of schizophrenia drug CTP-692 after reporting disappointing data from a Phase 2 clinical trial evaluating it...

Medical Devices

Soliton Rapid Acoustic Pulse Cellulite Device Cleared

FDA clears a Soliton 510(k) for its Rapid Acoustic Pulse device and technology for the short-term improvement in the appearance of cellulite.

Human Drugs

FDA Hits Fresenius with 6-item Form-483

FDA issues Fresenius Kabi a six-item FDA Form-483 after an inspection in May 2020 documented GMP deficiencies at its Melrose Park, IL manufacturing fa...

Medical Devices

Wahl Recalls Heat Therapy Massagers

Wahl Clipper Corp. recalls all Deluxe Heat Therapy Massagers, Model 4212, due to overheating concerns.