The Pharmaceutical Industry Calls for Expansion of the FDA’s PreCheck Program

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.