US FDA's Program Alignment: Where Should Form-483 Responses Go After May 15?
Now that FDA is aligning its enforcement program with its product centers on May 15, there are questions about who in the agency should receive manufacturers' 15-day responses to Form-483 inspectional observations.
You may also be interested in...
US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.
'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach
For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced by three distinct divisions across the US encompassing 20 FDA district offices on May 15. Check out the latest US map from the agency showing where the device divisions will be located, and find out what your firm will be facing at its next facility inspection.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.