FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary
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ByHeart Broadens Voluntary Recall While Investigation Continues
[New York, NY] – ByHeart, a next-generation baby nutrition company, announced today that it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food andEnviroServe Chemicals & Cleaners Ltd. – 674090 – 09/09/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/MisbrandedmRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following VaccinationLipari Foods Issues Allergy Alert on Undeclared Milk in “Dark Chocolate Nonpareils”
Lipari Foods of Warren, MI, is recalling its 14-ounce packages of JLM Branded “Dark Chocolate Nonpareils” food treats because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.FDA Rationale for Breakpoints Recognition Decision: Azithromycin and Neisseria gonorrhoeae
FDA Rationale for Breakpoints Recognition Decision: Azithromycin and Neisseria gonorrhoeaeUntitled Letters
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion’s untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.