The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007.
Rockville, MD (Sept. 5)-The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007. The drug products for which updated draft product-specific bioequivalence recommendations are available include: risedronate sodium, fosinopril sodium/hydrochlorothiazide, fluoxetine HCI/olanzapine, erlotinib HCI, and morphine sulfate.
In 2007, FDA announced in its draft guidance for industry, “Bioequivalence Recommendations for Specific Products,” that the agency was providing product-specific bioequivalence recommendations on its website to solicit public consideration and recommendations. The online process is intended to support drug manufacturers with abbreviated new drug applications.
Click here for the announcement of the new recommendations and here for the updated bioequivalence recommendations list. Comments on the updated recommendations can be made until Dec. 4, 2008.
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.