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The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...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The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses...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Draft guidance from the US Food and Drug Administration (FDA) outlines the agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics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...
France – FDA guidance calls for testing all alcohol-based products for methanol
The US Food and Drug Administration (FDA) issued final guidance to assist manufacturers and compounders in testing alcohol products (ethanol and isopropyl) for methanol....
USA – FDA offers guidance on development of antimicrobials for diabetic foot infections
The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused...
