The Alliance of Specialty Medicine sent a letter in response to the Food and Drug Administration‘s (FDA) Draft Report and Plan on Best Practices for Guidance, focusing on the agency’s request for feedback as it considers “opportunities to streamline processes for regulatory submissions through the revision and issuance of guidance documents and to implement innovative guidance development processes and practices,” and specifically, a proposal that would limit notice-and-comment for certain guidances.
The specialty doctors told the FDA, “[w]ithout prior notice-and-comment, it would be difficult, if not impossible, for FDA to fully appreciate how its guidances may impact affected stakeholders, including patients.” They urged the agency “to prioritize advance notice-and-comment when issuing Level 1 guidances. FDA should also include detailed examples and rationale of when Level 1 guidance may necessitate implementation without advance notice-and-comment, in addition to the COVID-19 PHE examples provided.” You can access the Alliance’s full response by clicking the link below.
