FDA

FDA Draft Guidance on 3-Year Exclusivity for Drug Products

The FDA has issued draft guidance to assist applicants requesting 3-year exclusivity for drug products. The guidance, available for public comment, clarifies the statutory and regulatory criteria for eligibility and provides recommendations on request content and format. This aims to support the Drug Competition Action Plan.

FDA Guidance on Real-World Data for Medicine Safety Assessment

The FDA has issued final guidance on using real-world data for medicine safety assessments, replacing a previous draft and withdrawing an older guidance. This document provides principles for planning, designing, analyzing, and reporting non-interventional studies utilizing real-world data for drugs and biological products.

FDA Warning Letter to Supercan Bully Sticks LLC

The FDA issued a warning letter to Supercan Bully Sticks LLC on September 24, 2025, following inspections that revealed serious violations of the Foreign Supplier Verification Program (FSVP) and Current Good Manufacturing Practice regulations. These violations were identified after a voluntary recall of pet treats due to Salmonella contamination.

FDA Warning Letter to GenoGenix LLC

The FDA issued a warning letter to GenoGenix LLC for serious deficiencies in drug production practices, including failures to meet conditions for outsourcing facilities and insanitary conditions. The company has ceased production and initiated a voluntary recall of drug products.

FDA Warning Letter to Strut Health, LLC

The FDA issued a warning letter to Strut Health, LLC on February 20, 2026, for misbranding compounded semaglutide and tirzepatide products. The company's website allegedly made false or misleading claims about these drugs, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Kare Solutions LLC dba Zappy

The FDA issued a warning letter to Kare Solutions LLC dba Zappy for misbranding compounded drug products, including semaglutide, tirzepatide, and liraglutide. The agency found that Zappy's website made false or misleading claims about these products, suggesting they were FDA-approved or compounded by Zappy when they were not.

FDA Warning Letter to Beta Bionics, Inc.

The FDA issued a warning letter to Beta Bionics, Inc. regarding violations of the Quality System Regulation for their iLet Dosing Decision Software and iLet ACE Pump. The letter details failures in corrective and preventive action procedures, including inadequate analysis of complaints leading to serious adverse health outcomes.

FDA Warning Letter to Diasol, Inc. for Medical Device Violations

The FDA issued a warning letter to Diasol, Inc. for manufacturing unapproved and misbranded medical devices, specifically disinfectants for hemodialysis systems. The company also violated Quality System Regulation requirements. The FDA has requested corrective actions to ensure compliance.

FDA Warning Letter to Yuyao City Boss Vegetable Factory

The FDA issued a warning letter to Yuyao City Boss Vegetable Factory Co. Ltd. for serious violations of food safety regulations, including failure to maintain processing records and fabrication of data. The violations relate to acidified foods intended for export to the United States.

FDA Warning Letter to John Yoder Farm

The FDA issued a warning letter to John Yoder Farm for serious violations of the Shell Egg Regulation (21 CFR Part 118) and the FD&C Act. The farm failed to implement a written Salmonella Enteritidis Prevention Plan and had other insanitary conditions. The FDA is concerned about the compliance status and potential health risks.