In releasing details of its plans for upcoming guidance document topics, the FDA reveals to industry what's on its mind. Consider this list in any upcoming ops planning.
Topics are organized by FDA center. On the drugs side, manufacturing topics break into chemistry and GMP/compliance. They include three guidance documents on chemistry, manufacturing, and controls: for postmarketing, for postapproval changes, and for comparability protocols for approved drugs. Standards recognition and drug residue in transdermal drug delivery systems also make the list.
The GMP compliance guidance list includes the current warning letter hot topic of contract manufacturing. Among other topics are component control, highly potent compound control, expiration dating for unit-dose repackaged drugs, and API importation.
On the biotech side, the list of manufacturing topics is shorter: CMC information for live biotherapeutic products in early clinical trials, and an update of bar code label requirements for vaccines.
The regulator invites comments.
- see the Annual Guidance Agenda (PDF)