The expert witness testimony made it clear that U.S. labs were treated differently than foreign ones, and despite increases in hiring at the FDA over the years, lawmakers have a lot to be concerned about when it comes to the FDA conducting proper oversight of foreign manufacturing facilities.
CPA’s report exposes that “Aurobindo does business with at least four suppliers that have ties to organizations under US sanctions for their connections to China’s military industry.”
The Active Pharmaceutical Ingredient Innovation Center (APIIC), a consortium of biotechnology industry, policy and academic leaders, said in a whitepaper released to the media on Jan. 24, that reshoring the manufacture of essential, life-saving pharmaceuticals was urgently needed.
A Chinese cancer drug maker that has not been inspected by the FDA since 2018 is selling chemotherapy drugs to the U.S. due to shortages. When will the U.S. meet its critical medication needs?
The U.S. is increasingly dependent on imports for drugs. One reason: a tax avoidance scheme that pits U.S. manufacturing up against Europe. What can be done about this problem?
The Covid-19 pandemic gave big pharma big payday. But it also caused the industry to rethink a globalized supply chain centered on Asia. What will it take to reshore at least some generic drugs to the U.S.
Senator Burr warned the FDA that until the Senate is okay with their response to the infant formula crisis, and present a plan to prevent it in the future, the Generic Drug User Fee Authorization bill might be put on hold.