USA – FDA publishes two guidances on collecting clinical outcomes data
The US Food and Drug Administration (FDA) has finalized two guidance documents in its series of guidances related to Patient-Focused Drug Development (PFDD). The...
USA – FDA moving in the right direction with psychedelic drug guidance
The US Food and Drug Administration’s (FDA) recent guidance on psychedelic drug development is a “policy landmark” and a step in the right direction...
USA – FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas
The US Food and Drug Administration (FDA) is ramping up its monitoring of firms in areas of the world considered high risk for manufacturing...
USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...
USA – FDA won’t extend LDT rule comment period
The US Food and Drug Administration (FDA) will not extend the comment period deadline for a proposed rule that would start phasing out its...
USA – FDA expands KASA review program to drug substances
The US Food and Drug Administration (FDA) is now piloting its Knowledge-aided Assessment and Structured Application (KASA) drug review program for drug substances as...
USA – FDA expands scope of off-label guidance to include presentations from reprints
The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses...
USA – Dems urge free OTC birth control while GOP fights to ban mail-order...
US Democratic senators have signed a letter to the Biden administration to issue guidances that ensure Perrigo’s over-the-counter birth control pill Opill (norgestrel) is...
USA – FDA addresses use of remote interactive evaluations in post-pandemic era
Draft guidance from the US Food and Drug Administration (FDA) outlines the agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics facilities...
USA – FDA finalizes guidance on considerations for evaluating drug’s benefits and risks
The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into...
