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Bulk Drug Substances Used in Compounding
Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to patients, sections 503A and 503B of the FD&C Act place limits on the bulk drug substances that can be used in compounding.Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences
Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriersAnimal Model Qualification Program | AMQP
Information for requestors interested in submitting animal models for qualification to FDA’s Drug Development Tool (DDT) Programs.Advanced Manufacturing Technologies Designation Program
FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products.Tropicale Foods Recalls Certain Helados Mexico and La Michoacana Products Due to Undeclared Milk
Tropicale Foods of Ontario, CA is recalling certain Helados Mexico and La Michoacana products with specific best by dates, as detailed below because these products contain undeclared milk.Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.
ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.