FDA Drug Diversion Act
Executive Summary
Proposed rule for state regulation of drug wholesalers is expected to be available within the next two weeks, FDA said. The guideline proposes minimum standards for storage and handling, record keeping, and licensing. States will use the guidelines as a basis for developing their own regulations. Wholesalers must be licensed by the state two years after FDA publishes the final rule, the agency said. In addition, a guidance letter to industry on implementation of the act is expected to be available the week of Aug. 1 ("The Pink Sheet" July 25, T&G-1).
You may also be interested in...
Amgen/AstraZeneca’s Tezepelumab Cuts Asthma Exacerbations By 56%
Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics.
Sarepta’s Next-Generation Drugs Draw Attention Amid ‘Incremental’ Approval
The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.
COVID-19 Will Forever Change Workplace, But Not Necessarily For The Better, Merck’s Frazier Says
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: