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September 27, 2022
The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such...
August 15, 2022
This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and...
June 27, 2022
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...
June 16, 2022
Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation...