FDA regulations

FDA requests public input on obesity's effects on drug pharmacokinetics and pharmacodynamics during development to inform safety, effectiveness, and dosing guidance for obese patients.

FDA seeks 60-day public comment on proposed exemptions from premarket notification requirements for certain class II clinical toxicology test system devices under 21st Century Cures Act procedures.

FDA classifies phototherapy devices for reducing acute post-surgical incision appearance as Class II medical devices, subject to special controls to ensure safety and effectiveness.

FDA classifies the laser-powered inferior vena cava filter retrieval catheter as a Class II medical device, requiring special controls to ensure safety and effectiveness for cardiovascular applications.

FDA classifies brain temperature measurement systems as Class II medical devices with special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

The FDA classifies radiation therapy marking devices as class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

The FDA determined that FENOGLIDE (fenofibrate) tablets at 40 mg and 120 mg strengths were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.

The FDA proposes to withdraw approval of ChemoCentryx's TAVNEOS (avacopan) capsule based on lack of substantial evidence of effectiveness and untrue material statements in the application, with opportunity for hearing.

FDA seeks 60 days of public comment on information collection requirements for Good Laboratory Practice standards in nonclinical laboratory studies.

FDA seeks OMB approval for juice processors and importers to implement hazard analysis and critical control point procedures under the Paperwork Reduction Act of 1995.

FDA determines that OZEMPIC semaglutide 2mg/1.5mL solution was not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.

FDA renews the Pharmacy Compounding Advisory Committee for an additional two years, extending its charter through April 25, 2028.

Pork King Good voluntarily recalls Sour Cream & Onion pork rinds and seasoning due to potential Salmonella contamination from milk powder ingredient.

FDA seeks input on a pilot program to evaluate AI-enabled technologies for improving efficiency and decision-making in early-phase clinical trials while maintaining regulatory standards.

Ghirardelli Chocolate Company recalls powdered beverage mixes due to potential Salmonella contamination linked to a California Dairies milk powder ingredient.