FDA officials are encouraging the pharmaceutical industry to switch from batch to continuous manufacturing, and they’re promising to help with the transition.
FDA Talks Up Continuous Manufacturing, Offers Assistance
It is time for drug makers to embrace continuous manufacturing methods, CDER Director Janet Woodcock and other FDA officials emphasize. Now the agency is offering additional support to help manufacturers move away from batch processes.
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Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
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.
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.
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
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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.
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
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.