Manufacturing
Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.
While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams.
The market outlook is full of uncertainty and pitfalls. Experts weigh in on how to mitigate risks.
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.
This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.
Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.
Pfizer CEO Albert Bourla directly credited the threat of tariffs with leading to the deal, in which the company will offer drugs on a soon-to-be-launched website called TrumpRx.
Companies are moving from using AI for distinct operations to applying the technology for control and optimization of the whole production process.
Reshoring generic pharmaceutical production is essential in today’s era of geopolitical instability and heightened awareness surrounding national health security. And it is possible—if done right.
The issues the regulator found include the failure to comprehensively review complaints and product defects.
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