FDA Related News

Human Drugs

AbbVie Antibiotic OKd for Abdominal Infections

FDA approves an AbbVie NDA for Emblaveo (aztreonam and avibactam), a combination antibiotic for combination use with metronidazole in patients with co...

FDA General

Senate Dems Denounce FDA Communication Freeze

A group of 24 Senate Democrats write HHS and urge an end to the ongoing and unprecedented freeze on all external communications and funding at governm...

Human Drugs

Insmed NDA Accepted for Brensocatib

FDA accepts for priority review an Insmed NDA for brensocatib for treating patients with non-cystic fibrosis bronchiectasis.

Medical Devices

Alert on Bards Rotarex Atherectomy System

FDA issues an alert about Bard Peripheral Vasculars Rotarex Atherectomy Systems due to risks of fracture or breakage.

Human Drugs

Use Preemption in Failure-to-Market Cases: PRI

A Pacific Research Institute white paper makes the case for a preemption defense in failure-to-market cases brought under state laws.

Court Threatens Practice of Medicine Defense: Attorneys

Cooley attorneys say a recent 4th Circuit Court of Appeals decision threatens the practice of medicine defense, giving FDA an additional enforcement m...

Human Drugs

Breakthrough Status for Mortality Prognosticator Tool

FDA grants Onc.AI a breakthrough device designation for its Serial CT Response Score AI model, which the company describes as an artificial intelligen...

Medical Devices

Medline Catheter Recall is Class 1

FDA says the Medline Industries recall of integrated arterial catheters is Class 1.

FDA General

Trump to Fire Thousands of HHS Workers: Report

Mainstream media reports based on anonymous sources say the White House is preparing an order to require HHS to fire a percentage of employees in FDA,...

Human Drugs

Cancer Drug Tabloid ANDA Restrictions Sought

A Buchanan Ingersoll petition asks FDA to maintain restrictions on cancer drug Tabloid ANDAs that are in the applicable product-specific guidance.