USA – FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme...
USA – FDA finalizes guidance on real-time review of oncology drugs
The US Food and Drug Administration (FDA) has finalized its guidance that outlines the eligibility and submission requirements for applicants interested in submitting new...
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The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...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The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses...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...
