- Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI<p>Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech indust…raps · 12d ago↗ source
- Cayman court says Apple Tree general partner should lose control of venture fundThe embattled venture firm Apple Tree Partners has suffered a loss in a Cayman Islands court case against its main limited partner. A judge in the Grand Court of the Cayman Islands ruled on Frida…Endpoints · 12d ago↗ source
- FDA finalizes guidance on psychedelics, plans broader hearingThe FDA has finalized clinical guidance for psychedelic drug developers and has scheduled a public hearing on future therapeutic use, adding regulatory momentum to a class on the precipice of appro…