FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.
To encourage additional compounders to register as outsourcing facilities, FDA has revised its draft guidance with a promise to enforce only a small subset of good manufacturing practice requirements when they produce small batches, as when compounding physicians’ office supplies in advance of receiving prescriptions.
The revision also adds guidance on non-sterile drug compounding, something industry complained was lacking in the first draft.
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
