The FDA has announced the establishment of a docket [ https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments ...
We are honored to serve as Chair and Vice Chair of the Chemistry, Manufacturing & Controls (CMC) Community and look forward to fostering knowledge sharing ...
NEW REGULATORY GUIDANCE SHARING THREAD Use this pinned post to share and discuss the latest regulatory guidance documents, updates, and ...
Thank you Allison for taking on this role! I am looking forward to continuing engagement with the regulatory community. ------------------------------ ...
Just my humble opinion, but I think we get too hung up on terminology. As I like to point out, in the GLP regulations (21CFR part 58), no where will you ...