FDA Related News

4 CBER SOPPs on Application Processing

CBER publishes four Standard Operating Policies and Procedures relating to application review responsibilities for various products.

Human Drugs

Bayer Reiterates Position on Apotex ANDA

Bayer pushes FDA to confirm that it will grant a 30-month stay before approving an Apotex ANDA for Bayers Astepro Allergy nasal spray.

Medical Devices

FDA, NYU Partner on Stroke Rehab Review Tool

FDA and researchers from New York University partner to design a regulatory science tool to improve the review processes for stroke rehabilitation dev...

Human Drugs

FDA Biosimilar Regulatory Science Program Opens

FDA is soliciting projects to fund under a new pilot program to enhance regulatory science for biosimilars and interchangeable products.

Human Drugs

Manufacturing Woes Lead to Natpara Discontinuation

Takeda says it will discontinue manufacturing Natpara (parathyroid hormone) for injection due to manufacturing woes that caused protein particle forma...

Human Drugs

Accelerated Approval Pathway Possible for Emphysema Drug

FDA tells Inhibrx that there is potential to pursue an accelerated approval for INBRX-101 for treating patients with emphysema due to alpha-1 antitryp...

Human Drugs

Rare Disease Endpoint Advancement Pilot

FDA launches a Rare Disease Endpoint Advancement pilot program as called for in the PDUFA 7 reauthorization.

Medical Devices

Flawless Beauty and Skin Selling Illegal Products: FDA

FDA warns Ocean, NJ-based Flawless Beauty and Skin that it is illegally distributing imported medical devices used in skin care.

Human Drugs

CGMP Violations at Sterling Pharmaceutical

FDA warns Dupo, IL-based Sterling Pharmaceutical Services about CGMP and other violations in its production of finished drugs.

Human Drugs

FDA Meets STAR Pilot Commitment

FDA starts the Split Real Time Application Review pilot program called for in the PDUFA 7 reauthorization.