Regulatory Focus

USP wants to see only cautionary statements on the caps of injectable products.

FDA assists manufacturers with labeling of devices and packaging containing rubber.

As part of a document for IND applications, FDA�s new guidance covers packaging for clinical trials.

FDA focuses efforts on draft guidances for 21 CFR Part 11 and comparability protocols.

A new guidance covers bracketing and matrixing for the stability testing of drugs.

After a lengthy delay, the agency has pared down a final version and prepared it for publication.

FDA's concept paper offers guidance on isolators and blow-fill-seal operations.

FDA's guidance helps ANDA holders avoid multiple drug relabeling.

FDA's draft guidance addresses the maintenance of electronic records.

FDA's review of CGMPs focuses on introducing new technologies and developing a more consistent approach to evaluating quality systems.