FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner.
Similar Posts
Giant Eagle Recalls Smoked Mozzarella Pasta Salad Due to Potential Listeria Monocytogenes Contamination Associated with Nationwide Recall from Nate’s Fine Foods
PITTSBURGH – Giant Eagle, Inc., has issued a voluntary recall of “Smoked Mozzarella Pasta Salad” sold in the prepared foods departments of its Giant Eagle and Market District locations across western Pennsylvania, Ohio, Maryland and Indiana due to potential listeria monocytogenes contamination. ThisShopaax.com – 626291 – 07/01/2022
Interstate Commerce/Food/AdulteratedAlvotech HF – 07/04/2025
Alvotech HF – 07/04/2025. Country: Iceland. Record Type: 483FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients
The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market.Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/03/2025
Short Title (70 char) Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
FEI Number 3003434972
Firm Name Wedgewood Connect, LLC
Record Type 483
State CA
Establishment Type Outsourcing FacilitJanssen Vaccines Corp., A Johnson & Johnson Company – 713194 – 07/18/2025
CGMP/Finished Pharmaceuticals/Adulterated