US FDA Requests Frequent Updates On Supply Chain Disruptions In COVID-19 Era
Pharmaceutical companies struggling to keep up with coronavirus-related supply chain havoc asked to keep the US regulator informed as situation unfolds.
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Hours before the US FDA confirmed the first drug shortage due to active pharmaceutical ingredient constraints because of the coronavirus situation in China, generics industry leader Mylan came under pressure about the potential impact on its business.
New import alert category and border testing required after reduced standards put dangerous sanitizers into hands of US consumers.
New COVID-19 Vaccines May Be Accelerated By Using Existing Manufacturing Platforms, US FDA's Marks Says
FDA's CBER director says the development of new COVID-19 vaccines can be accelerated by using manufacturing platforms developed for other types of vaccines, thereby reducing the need for product-specific data.