FDA Draft Q&As on Biosimilar Development and BPCI Act

The FDA has issued a draft guidance document providing updated answers to common questions regarding biosimilar development and the Biologics Price Competition and Innovation Act (BPCI Act). This revision replaces a previous draft and focuses on specific Q&As related to the abbreviated licensure pathway for biological products.

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.

CMA Finalizes Water Company Bill Increases

The UK's Competition and Markets Authority (CMA) has issued a final decision on disputed price controls for five water companies, allowing an average bill increase of 2.2%. The CMA rejected 83% of the increases sought by the companies, granting £463 million in additional revenue, down from a provisional £556 million.

CMA Report on Agentic AI's Consumer Impact

The UK's Competition and Markets Authority (CMA) has published a report analyzing the potential impact of agentic AI on consumers. The report outlines how agentic AI is currently used, its future implications, and provides guidance for businesses on mitigating risks.

CMA Guidance on Consumer Law for AI Agents

The UK's Competition and Markets Authority (CMA) has published new guidance for businesses on complying with consumer protection law when using AI agents. The guidance clarifies that businesses remain responsible for the actions of AI agents they deploy and outlines how to train them to ensure legal compliance.

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 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 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 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.