FDA Study Finds Geography Not A Good Predictor Of Quality for Hard-To- Make Drugs
An FDA study asserts that where a drug is made is not necessarily a good indicator of its quality, and that for some hard-to-make drugs, the same manufacturing problems affect drugs in the US as in other parts of the world.
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Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.
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.