Medical Device Legal News with Sam Bernstein: Episode 11
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more
On Sept. 18, 2023, 19 Democratic state attorneys general (AGs) filed public comments to the Draft Merger Guidelines (Draft Guidelines) proposed by the U.S. Department of Justice and the Federal Trade Commission (the Agencies)...more
In the second edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administrations’ (FDA) expectations of investigators articulated in the recently released draft guidance....more
The Food and Drug Administration (FDA) recently issued first-of-its kind draft guidance for investigational new drug (IND) applications involving psychedelic drugs. Citing the rise in interest in exploring the potential...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
Specific compliance considerations apply to M&A transactions and public tenders. On 12 January 2023, the Foreign Subsidies Regulation (FSR) entered into force. The FSR empowers the European Commission (Commission) to...more
The Washington State Department of Ecology (“WSDE”) issued a December 2022 document titled: Draft Guidance for Investigating and Remediating PFAS Contamination in Washington State (“Guidance”)...more
In February, the California Department of Toxic Substances Control, or DTSC, the State Water Resources Control Board, or SWRCB, and the San Francisco Bay Regional Water Quality Control Board released a much-anticipated draft...more