The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
The U.S. FDA’s recent final guidance for clinical decision support (CDS) software has drawn a second citizen’s petition for withdrawal, this time from a law professor at the University of Florida (UF). Barbara Evans of the UF School of Law asserted that the CDS final “raises constitutional issues” that are of sufficient importance to warrant an investigation led by the FDA commissioner’s office because of what she argues is a disregard for the First Amendment encoded in the guidance.
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
The U.S. FDA raised some hackles with its final guidance for clinical decision support (CDS) software, thanks to provisions that some stakeholders argued flew against congressional intent regarding the regulatory status of some device functions. That final guidance is now the target of a petition by the CDS Coalition to withdraw and rewrite the final guidance, arguing that the agency is “doing an end run” around the limitations established by Congress regarding the FDA’s oversight of software as a medical device (SaMD).
After more than five years and extensive feedback, the U.S. FDA is finalizing its guidance on the format and content of risk evaluation and mitigation strategy (REMS) plans for prescription drugs and biologics associated with serious risks.
Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.”
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
