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
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.