The FDA Public Engagement Staff is responsible for managing the agency’s Patient Listening Session program. This page contains a list of all the Patient Listening Sessions that […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER March 26, 2024 RE: 701480 Dear Andy […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Robert P. Nickell Recipient Title CEO Nubratori, Inc. dba Nubratori […]

Delivery Method: VIA UPS Reference #: 320-25-62 Product: Drugs Recipient: Recipient Name Ms. Lina M. Kennedy Recipient Title President and CEO PMS4PMS, LLC 4255 Research PkwyClarence, […]

Español [4/14/2025] FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were in the U.S. […]

On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line […]

The following is a list of meetings that have occurred between FDA and stakeholders on the topic of sunscreens. November 1, 2024: Listening session with Environmental […]

For Immediate Release: April 10, 2025 Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing […]

On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and […]