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Regulatory Focus Articles RSS Feed 2.0
21 October 2021
Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday said it wil...

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21 October 2021
The US House of Representatives on Tuesday night passed a bill, H.R. 4369, that promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing at various universities across the country.
21 October 2021
US Department of Health and Human Services (HHS) officials are proposing to repeal two rules issued in the final days of the Trump Administration, calling them a “burden” and “inconsistent with the policies and goals of the current Administration.”
21 October 2021
The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking feedback on ...