What Not To Do When FDA Comes Knocking
This article was originally published in PharmAsia News
The U.S. FDA tweaks final guidance on what constitutes interference with FDA inspections to include examples of ‘reasonable’ explanations for sponsor delays; industry had requested many other changes.
You may also be interested in...
Sterile areas, cell therapies, and security systems are just a few of the items where industry wants FDA inspector access limited without triggering a new law that would make products in a facility deemed adulterated.
FDA has a powerful new tool to assure access to drug manufacturing plants: legislated authority to deem a product adulterated when a company tries to evade inspections: A new guidance elaborates on the situations that FDA will define as obstructionist, and cuts into new territory by defining refusal to provide records in lieu of an inspection as an actionable offence.
From the rise of DTC to the shadow of Caronia, Abrams, the long-time head of the Office of Prescription Drug Promotion, monitored dramatic changes in the pharmaceutical marketplace and regulatory environment. He retired from FDA on 23 October after a tenure marked as much by careful research projects and copious guidances as it was by promotional and legal upheavals.