To further accelerate adoption of new pharmaceutical manufacturing technologies, the US Food and Drug Administration’s Center for Drug Evaluation and Research is adding staff to its Emerging Technology Program and “graduating” technologies to standard quality assessment pathways.
US FDA Program Adds Staff, Graduation Concept To Help Advance Newer Manufacturing Technologies
Agency will expand staffing to address requests for help from its Emerging Technology Program, while “graduating” technologies with which it gains sufficient experience.
More from Manufacturing
• By
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
• By
A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
• By
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
• By
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.
More from Compliance
• By
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.
• By
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.
• By
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.