This article was originally published in The Gray Sheet
One detail in the draft guidance that may catch the attention of some in industry is in the section on technology, engineering and performance changes.
You may also be interested in...
The Institute of Medicine committee charged with reviewing FDA's 510(k) device pre-market review program is urging the agency to ditch the 35-year-old program and start fresh.
Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.
Zydus Cadila is to begin testing a three-dose recombinant DNA vaccine candidate in Phase III Indian trials, which might enter late-stage development ahead of Inovio and AnGes. The company promised to provide 100-150 million doses by end of 2021 at the J.P. Morgan Conference, though adherence could be a roadblock.