Shortage of generic cancer drugs should trigger FDA AA actio
Shortage of generic cancer drugs should trigger FDA and EU action to increase the level of Accelerated Approvals (AA) of new cancer biologics to begin addressing the generic cancer drug shortages that have been experienced in NA and Europe for the past several years and which are expected to continue into the foreseeable future.
The issues with generic cancer drug production stem from the fact that most are commonly manufactured in India and the FDA has continued to issue countless manufacturing violation letters to those Indian manufacturers producing drugs that are intended for use in North America and Europe.
https://endpts.com/short-supply-of-commonly-used-cancer-drugs-raises-concerns-among-hospital-pharmacists/
https://www.euractiv.com/section/health-consumers/news/berlin-aims-to-fend-off-drugs-shortages-without-general-prices-adjustments/