New incentives to increase drug manufacturers’ internal facility oversight could include less external, such as US Food and Drug Administration, oversight of them.
Firms Could Earn ‘Platinum Card,’ Less Frequent Inspections With Third-Party Audits, Califf Says
Increasing data flow into the agency could improve inspection decision-making.
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
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Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
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Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.