FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health
FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. This is due to potentially dangerous hidden drug ingre
New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation
View details about the NDRP Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for comments
New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation
View details about the NDRP Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for comments
Niitakaya USA Inc. Issues Allergy Alert on Undeclared Allergen of Fish (Bonito) in #3700 Shiso Katsuo Ninniku/#3701 Miso Katsuo Ninniku
Niitakaya USA Inc. of Montebello, CA, is recalling All Best By dates of its 5.2 ounce (147 gram) packages of #3700 Shiso Katsuo Ninniku /#3701 Miso Katsuo Ninniku because they may contain undeclared A
CDER Nitrosamine Impurity Acceptable Intake Limits
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information
Prescriber Perceptions of Boxed Warnings: A Qualitative study
CDER research finds that boxed warnings are only one of several factors that influence prescriber treatment decisions.
Oncologic Drugs Advisory Committee Charter
This is the Charter for the Oncologic Drugs Advisory Committee.
FDA Roundup: August 30, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S. - 659854 - 08/14/2024
CGMP/Finished Pharmaceuticals/Adulterated
2024 Meeting Materials, Pharmacy Compounding Advisory Committee
2024 Meeting Materials, Pharmacy Compounding Advisory Committee
October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 10/29/2024
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., Bldg. 31 Conference Center, the Great Room.
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