ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA - 09/10/2024
ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA
FDA Roundup: September 6, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
2024 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
This page contains the meeting materials for the Cardiovascular and Renal Drugs Advisory Committee meetings for 2024.
October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee - 10/10/2024
The Committee will discuss new drug application (NDA) 215244, for elamipretide hydrochloride injection, submitted by Stealth BioTherapeutics Inc., for the treatment of Barth Syndrome.
Milo’s Poultry Farms, LLC., Recalls Eggs Because of Possible Health Risk
Milo’s Poultry Farms, LLC. of Bonduel, WI is recalling all “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs because these eggs have the potential to be contaminated with Salmonella, an or
Hammond’s Candies Issues Allergy Alert on Undeclared Milk in Hammond’s Dark Chocolate Filled Mini Waffle Cones
Hammond’s Candies of Denver, CO is recalling 4-ounce bags of Dark Chocolate Filled Mini Waffle Cones because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk
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.