Post-Warning Letter Meetings Under GDUFA

DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.

Africa Imports is voluntarily recalling its Organic Moringa Leaf Powder (1 kilogram box) because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, the elderly, and individuals with weakened immune systems. Healthy persons inf

Monthly and quarterly metrics of the FDA Generic Drugs Program.

This webinar will provide an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver” that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.

Goodlettsville, Tennessee – August 11, 2025 –Dollar General Corporation is recalling three (3) lots of its eight (8) ounce Clover Valley® Instant Coffee due to the potential presence of glass.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program