RMAT Designation Enables Critical Manufacturing Discussions – FDA's Marks
Designation of cell and gene therapies as regenerative medicine advanced therapies is enabling deeper interaction with the US FDA on manufacturing challenges, says the head of the agency's biologics center.
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Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.
The Quality Lowdown: Warning Letters, Nitrosamine Recalls And Sen. Warren's Generics Manufacturing Plan
Manufacturers warned on quality basics like testing and keeping records and reminded about nitrosamine deadlines; Senator Elizabeth Warren clarifies government drug manufacturing idea.
New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.