FDA Releases Pulmonary Tuberculosis Guidance
FDA releases guidance on pulmonary tuberculosis drugs.
FDA has released a draft guidance, Pulmonary Tuberculosis: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs for the treatment of pulmonary tuberculosis. The guidance document addresses the overall development program and clinical trial designs for drugs to support an indication for the treatment of active pulmonary tuberculosis. The guidance applies to the development of a single investigational drug as well as to the development of two or more new investigational drugs for use in combination.
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.
