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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 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 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 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.

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.

Ford Escape, Bronco Sport Recall - Fuel Injector Crack

Transport Canada has issued a recall for certain 2020-2022 Ford Escape and Bronco Sport vehicles due to a potential fuel injector crack, which could lead to a fuel leak and fire risk. Ford will notify owners to update software and install a drain tube, with an extended warranty for injector replacement.

Transport Canada Truck Recall - Electrical Issue

Transport Canada has issued a recall for certain Western Star and Freightliner trucks due to an improperly installed tarp system relay that poses a fire risk. Owners will be notified by mail to inspect and potentially reinstall the relay.

Ford SUV Recall - Fuel Injector Leak Risk

Transport Canada has issued recall 2024160 for certain 2022-2023 Ford Escape and Bronco Sport models due to a risk of fuel leaks from cracked fuel injectors, which could lead to engine compartment fires. Ford will notify owners to update software and install a drain tube, with an extended warranty for injector replacement.