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Congress Pressures DHS To Expedite Safety Act Approvals

Client Alert | 1 min read | 10.06.06

During House Homeland Security Subcommittee hearings on DHS implementation of the SAFETY Act, C&M's David Bodenheimer testified that the new regulations (71 Fed. Reg. 33147) and application kit (available at https://www.safetyact.gov/) have simplified the process, but further improvements are needed to (1) assure confidentiality of SAFETY application data, (2) encourage breakthrough technologies, (3) synchronize procurements and SAFETY Act approvals, (4) extend the duration of protection, and (5) establish an appeals process. In these same hearings, the new DHS Under Secretary (Science & Technology) identified additional initiatives to encourage new anti-terrorism technologies by reducing the application cycle to 120 days and identifying more technologies suitable for block approvals.

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Client Alert | 2 min read | 09.18.25

FDA Announces Intention to Initiate an Aggressive Enforcement Campaign Against Misleading Pharmaceutical Advertising

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (HHS) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”...