The Rare Diseases Program facilitates, supports and accelerates the development of drug and biologic products for the benefit of patients with rare disorders
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Clinical Outcome Assessments (COA) Qualification Program Resources
Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program.This update contains the Letter of Intent Template for the COA Qualification Program, as described under section 507 of the Federal Food, Drug, and Cosmetic Act.
Notable Approvals | Drugs
News about human drug-related approvalsViva Raw Issues Voluntary Recall of Two Lots of Dog an Cat Foods Due to Salmonella and Listeria Monocytogenes Contamination
August 25, 2025 – Viva Raw LLC, Charlotte, NC is voluntarily recalling two lots of dog and cat foods due to contamination with Salmonella and Listeria monocytogenes. The recall is for Lot 21495 (Viva Ground Beef for Dogs; Viva Beef & Turkey for Puppies) and Lot 21975 (Viva Ground Chicken for Dogs;Primavera Nueva Inc. Issues Voluntary Recall of Select 4-Count Tamales Because of Possible Health Risk- Revised to Include Roasted Pumpkin & White Cheddar, a Seasonal Item
Sonoma, CA — Primavera Nueva Inc. is voluntarily recalling certain lots of its 4-count tamales because the products have the potential to be contaminated with Listeria monocytogenes, an organism whichSection 804 Importation Program Policies and Authorizations
FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
FEI Number 3022897129
Firm Name Hikma Injectables USA Inc.
Record Type 483
State NJ
Establishment Type Outsourcing Fa