FDA/MHRA/Health Canada Symposium: Regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice – 06/02/2026

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/18/2025
Short Title (70 char) QuVa Pharma, Inc. Sugar Land, TX. Untitled Letter issued 06/18/2025
FEI Number 3012053582
Firm Name QuVa Pharma, Inc
Record Type 483
State TX
Establishment Type Outsourcing Facil

Inotiv Inc. – 10/24/2025. Country: United States. Record Type: 483

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.

The Food and Drug Administration is advising consumers not to purchase or use ZapMax, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices.

CGMP/Finished Pharmaceuticals/Adulterated