Regulatory Focus

Warning: Keep off the Caps

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

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Natural Rubber Guidance

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

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Guidance for Clinical Trials Packaging

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

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Update on CGMP Revisions

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

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Reduced-Design Stability Studies

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

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FDA to Publish Stability Guidance

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

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Aseptic Processing Update

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

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Labeling Update for Generic OTC Drugs

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

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For the (Electronic) Record

FDA's draft guidance addresses the maintenance of electronic records.

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A CGMP Makeover

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

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