FDA Extends Comment Period on ANDA Rule
FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.
FDA announced on April 15, 2015 that it was extending the comment period for the agency’s proposed rule on abbreviated new drug applications (ANDAs) and 505(b)(2) applications to June 8, 2015, in response to requests for more comment time. The rule, published in the Federal Register on Feb. 6, 2015, was proposed “to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and ANDAs. FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.”
Comments can be submitted online using docket number FDA-2011-N-0830.
Source: FDA.gov
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
