Regulatory Affairs

FDA Consolidates, Focuses MAPP Document on IND Clinical Holds

The FDA revised its Manual of Policies and Procedures document pertaining to issuing complete and partial clinical holds, including a reorganized background section that consolidates descriptions of IND clinical hold procedures, CFR citations and timelines for agency responses to sponsors. The new version also narrows its focus by omitting references to general IND review procedures included in the previous version that took effect in May 1998. Read More

Stakeholders Seek Clarification of RMAT Eligibility Criteria

Biocom and Gilead Sciences asked the FDA for clarification on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups requested more data on the success of the program. Read More