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Tag: FDA

Coronavirus / Health

FDA scientists propose an annual Covid shot matched to current strains

23.01.2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted …

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First Opinion / Health Tech

Opinion: Four types of bias in medical AI are running under the FDA’s radar

09.01.2023

Although artificial intelligence is entering health care with great promise, clinical AI tools are prone to bias and real-world underperformance from inception to deployment, including the stages of dataset acquisition, …

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Health

‘It’s taken longer than I thought’: A former FDA commissioner on the loosened restrictions on abortion pills

07.01.2023

When the Food and Drug Administration lifted some — but not all — of its restrictions on an abortion pill this week, it raised questions about why these rules were …

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Coronavirus

Priorities pile up for HHS, FDA, CMS, NIH, and other health agencies

03.01.2023

WASHINGTON — The nation’s health agencies already have a long to-do list for 2023. Top officials have promised reforms in the food, drug, and public health departments as frustrations mount …

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First Opinion

Opinion: The Aduhelm Operetta: ‘I’ve got a little list’

01.01.2023

The Congressional report on the FDA’s approval of Aduhelm makes some good points. As regulatory science advances, so too must the FDA’s administrative procedures. But this report mustn’t be seen …

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Biotech / Pharma

FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation

29.12.2022

Congressional investigators sorted through more than 500,000 pages of documents from the Food and Drug Administration and Biogen to chronicle how a controversial Alzheimer’s disease drug was approved, and how …

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Health

New FDA guidance explains that Plan B is not an abortion pill

24.12.2022

The Food and Drug Administration on Friday altered the language attached to emergency contraceptive pills to clarify that they are not abortion drugs. The agency’s update eliminates previous language that …

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Biotech / Pharma

Pharma wins changes in bill regarding FDA’s accelerated approval

20.12.2022

A bill that makes it easier for the Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline also dropped provisions the industry had opposed, according …

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First Opinion

Opinion: Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics

05.12.2022

Congress is considering two measures that modernize tools the Food and Drug Administration uses to oversee two areas of its vast portfolio: diagnostic tests and cosmetics. While the stakes are …

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