December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 12/04/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products - 10/07/2024
The purpose of this workshop is to engage stakeholders industry, academia, and FDA in a discussion on the scientific and regulatory challenges associated with immunogenicity risk assessment for propos
Medical products for rare diseases and conditions
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/dis
M&P Food Production Issues Allergy Alert on Undeclared Wheat and Milk in Vareniki, Pirozhki, and Blintzes
M&P Food Production Ltd. of Brooklyn, NY is recalling multiple flavors of blintzes, pirozhki, and vareniki, because it may contain undeclared wheat, milk, and/or sesame. People who have an allergy
Asli Fine Foods . Recalls Asli Cinnamon Powder 7 oz Because of Possible Health Risk
Asli Fine Foods of Woodridge, IL is recalling Asli Cinnamon Powder 7 oz, because it has the potential to be contaminated with Lead, Short term exposures to very low levels of lead may not elicit any s
AnuMed International, LLC - 674310 - 08/20/2024
Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded
FDA Roundup: August 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
What Does FDA Approve? Part 2
The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. FDA is here to provide the facts.
April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Letter of Support (LOS)
This is a letter issued to a requester that briefly describes CDER’s thoughts on the potential value of a biomarker and encourages further evaluation. This LOS does not imply qualification of a biomar
Cardiovascular and Renal Drugs Advisory Committee Charter
The Cardiovascular and Renal Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required.
FDA Roundup: August 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Sunco & Frenchie Issues an Allergy Alert on Undeclared Sulfites in Golden Raisins
Sunco & Frenchie LLC of Pine Brook, New Jersey is recalling its 10oz Terrafina Golden Raisins because they may contain undeclared sulfites. People who have an allergy or severe sensitivity to
Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds in Bliss Tree Butter Snacks
Sri Lakshmi Narasimhar Overseas LLC of Edison, New Jersey is recalling the following products because Bliss Tree Butter Snacks may contain undeclared milk and/or sesame seeds. The presence of undeclar
Gutierrez Distributor Expands Recall of Ground Cinnamon Because of Possible Health Risk
Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp and Gutierrez brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposure
Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth
Authentik Fudge of Sainte-Julie, Quebec, Canada, is recalling 840 units of Chocolate Fudge with Nuts branded MONTREAL FUDGE, due to potential mold growth contamination.
AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter
East Windsor, New Jersey, AuroMedics Pharma LLC has initiated a voluntary recall of lot number CPB200013 of Polymyxin B for Injection USP, 500,000 Units/Vial, to the consumer level from the USA market
Unilever U.S. Issues Allergy Alert on Undeclared Milk in Popsicle Jolly Rancher SingleServe Frozen Confection Pops
Unilever in the United States is recalling approximately 137,000 cases of Popsicle Jolly Rancher Frozen Confection Pop products (single serve offerings) because the products may contain milk, which is
Electronic Regulatory Submission and Review
This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.
Global IDMP Implementation - Getting Closer to the Goal - 10/16/2024
Global IDMP Implementation - Getting Closer to the Goal
FDA Roundup: August 20, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Flagstone Foods, LLC. Allergy Alert on Undeclared Peanuts, Almonds and Pecan in Emerald Kettle Glazed Walnuts
Flagstone Foods, LLC., manufacturer of Emerald Nuts, is issuing a voluntary recall of 6.5oz Emerald Kettle Glazed Walnut lot 2EE06284 because packages contain undeclared Peanuts, Almonds and Pecans.