US FDA

PDUFA and BsUFA Quarterly Hiring Updates

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa

LLK TRADING INC. of Linden, NJ, is recalling its 200g packages of “Needle Mushrooms” because it has the potential to be contaminated with Listeria monocytogenes

This page contains the Gastrointestinal roster, which lists the current members and the current number of vacancies for the committee.

The public meeting will be held on September 19, 2025, from 9 a.m. to 1 p.m. The meeting agenda, federal register notice, additional materials, and any other updates will also be posted to this website as they become available.

Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of serious or life-threatening allergic reactions if they consume these

The FDA today published more than 200 decision letters, known as complete response letters (CRLs).

NATCO Pharma Limited – 6/19/2025. Country: India. Record Type: 483

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.

Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.

AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.

Sun Pharmaceutical Industries Ltd. Country: India. Record Type: 483