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.
Insights
Client Alert | 5 min read | 04.13.26
EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal
In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA), We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
Client Alert | 4 min read | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26
Client Alert | 4 min read | 04.10.26
FTC Issues Five-Year Strategic Plan: What Businesses Need to Know
