fda

FDA Q&A on Biosimilar Development and BPCI Act

The FDA has reissued its final guidance on biosimilar development and the BPCI Act, solely to withdraw three specific Q&As (I.8, I.10, and I.19). The agency is continuing to evaluate other Q&As for potential updates.

FDA Warning Letter to Peaks Curative for False Claims

The FDA issued a warning letter to Peaks Curative, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented its compounding practices and implied FDA approval for products that are not FDA-approved, leading to misbranding violations.

FDA Warning Letter to Ivim Services LLC for Misbranded Drugs

The FDA issued a warning letter to Ivim Services LLC for introducing misbranded compounded semaglutide and tirzepatide products into interstate commerce. The agency found that Ivim's website made false or misleading claims, suggesting Ivim was the compounder when it was not, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to PharmaZee for False Claims

The FDA issued a warning letter to PharmaZee for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that PharmaZee misrepresented itself as the compounder and implied FDA approval for these unapproved drugs, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Refills Health for False Claims

The FDA issued a warning letter to Refills Health, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented itself as the compounder and made unsubstantiated claims such as 'clinically proven,' leading to the products being considered misbranded under the FDCA.

FDA Warning Letter to Good Girl LLC for False Claims

The FDA issued a warning letter to Good Girl LLC (dba GoodGirlRX) for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The company claimed the products were 'FDA-approved' and that GoodGirl RX was the compounder, which the FDA states is false and misbrands the drugs.

FDA Warning Letter to Lean Rx Inc. dba SkinnyRx

The FDA issued a warning letter to Lean Rx Inc. dba SkinnyRx for misbranding compounded semaglutide and tirzepatide products. The agency cited false or misleading claims on the company's website regarding the compounding of these drugs and their relation to FDA-approved medications.

Integra LifeSciences Recalls MediHoney and CVS Wound Dressings

The FDA announced a recall initiated by Integra LifeSciences for certain MediHoney and CVS Wound Gel products due to packaging failures that could lead to infection or delayed care. The recall involves removing affected products from service and distribution. Integra LifeSciences has reported 11 serious injuries related to MediHoney and three related to CVS Wound Gel.

Draft Guidance: Responding to FDA Form 483 Observations for Drug Manufacturers

The FDA has issued draft guidance for drug manufacturers on how to respond to observations noted on FDA Form 483 following CGMP inspections. This guidance is intended to assist domestic and foreign manufacturers in assessing conformity with CGMP requirements.

Medline Industries Recalls Catheters Due to Particulates and Infection Risk

The FDA has identified a Medline Industries catheter recall as the most serious type due to potential particulates causing infection or embolism. Affected product lots must be destroyed. This is an expansion of a previous recall.