FDA Promises Shorter, Quicker Drug GMP Warning Letters
This article was originally published in The Gold Sheet
No more discursive treatises, the agency promises. From now on, drug GMP warning letters are going to be short and to the point – and they're going to arrive much more quickly.
You may also be interested in...
Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?
'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.
US Interim Funding Bill Gets Biden’s Signature; Window Narrows For Cosmetics, Dietary Supplement Legislation
Passed by the US House and signed into law on 30 September, the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, avoids a partial government shutdown and furloughs in FDA user-fee programs. Policy riders stripped from the legislation, including for cosmetics and dietary supplement regulatory changes, could still find their way into a final FY 2023 spending omnibus.