FDA Pilot Program Creates New Path for Faster Regulatory Review of Generic Drugs

FDA Pilot Program Creates New Path for Faster Regulatory Review of Generic Drugs

The FDA will provide faster regulatory review of generic drugs that are tested in and manufactured in the U.S. using domestically sourced active pharmaceutical ingredients. This FDA pilot program is part of a broader Trump administration strategy to reshore pharmaceutical production. The post FDA Pilot Program Creates New Path for Faster Regulatory Review of Generic Drugs appeared first on MedCity News.

FDA pilots fast-track scheme for US-made generics

In another effort to boost domestic drug manufacturing, the FDA is piloting fast-track reviews for generics tested and made in US facilities.

FDA launches pilot program to improve US generic drug manufacturing

The FDA has revealed a new pilot program, dubbed the abbreviated new drug application (ANDA), which will encourage drugmakers to use domestic supplies of active pharmaceutical ingredients for generic drugs. The new program will speed ...

FDA backs generics onshoring push with ANDA priority scheme - Pharmaceutical Technology

Through the FDA's ANDA scheme, drug manufacturers who test and produce their generic medicines on US soil can now seek priority review.

FDA launches pilot program to prioritise review of U.S. made generic drug applications - Express Pharma

The U.S. Food and Drug Administration (FDA) has announced a new pilot prioritisation program for the review of abbreviated new drug applications (ANDAs). The program is designed to support investment in U.S.-based drug manufacturing and research and development, and to strengthen the domestic pharmaceutical supply chain by offering faster reviews to generic drug companies that conduct testing and manufacturing in the United States. According to …

FDA pilots fast-track scheme for US-made generics – RamaOnHealthcare

In another move designed to reduce the US's reliance on imported medicines, the FDA has launched a pilot of fast-track reviews for generics tested and made in domestic facilities.According to the regulator, applicants who conduct any required bioequivalence testing in the US, and whose products are made there using exclusively domestic sources for active pharmaceutical [...]