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Congress Pressures DHS To Expedite Safety Act Approvals

Client Alert | less than 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 | 5 min read | 05.12.26

EU Pharma Package: Advertising Compromise Proposal

In our ninth alert in this EU Pharma Package Series, we discussed the proposals of the Commission, Council, and Parliament with respect to advertising of medicinal products....