The Trump Administration’s regulatory freeze could slow FDA’s release of new guidance documents in 2017 and has raised questions within the biopharma industry about a potential effect on some long-awaited guidance documents that were released in the last two months.
Several guidance documents required under the FDA Safety and Innovation Act (FDASIA) of 2012 remain outstanding, and their release could be further prolonged by the Jan
Regulatory Freeze Pending Review
“The requirements of this memorandum apply to ‘any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking,’ and also covers any agency statement of general applicability and future effect
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