PDUFA Performance Reports

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr

Monthly and quarterly metrics of the FDA Generic Drugs Program.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/14/2025
Short Title (70 char) Pine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
FEI Number 3010943533
Firm Name Pine Pharmaceuticals LLC
Record Type 483
State NY
Establishment Type

BROOKLYN, N.Y., Feb. 27, 2026 /PRNewswire/ — USALESS.COM is recalling its RHINO CHOCO VIP
10X, in 10 gr, 12 pc packages that come in a black cardboard box marked with UPC Code 724087947668 on the back and with an expiration date of 10/2027 stamped on the back. The product is sold in retail stores a

Prime Food Processing LLC of Brooklyn, NY is voluntarily recalling 2,243 cases of two dessert bun varieties because the packaging does not declare milk in the “Contains” allergen statement as required by the U.S. Food and Drug Administration (FDA). The milk in these products is derived from unsalted

Unapproved New Drugs