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Opinion: STAT+: There’s a better way to get drugs on the market: progressive approval

STAT

regulatory system evolved to be more risk-averse as the FDA takes live fire every time an approved medication leads to severe adverse side effects and deaths. It also means that we all have to embrace the simple truth that taking these chemicals will always come with risk.     The U.S.

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USDA, FDA turf battles hamper responses to outbreaks like H5N1 bird flu

STAT

WASHINGTON — On a bright June day in 2018, one of the nation’s top regulators waved groceries in the air, quizzing the secretary of agriculture on which agency is charged with monitoring different types of food. The eggs, under the FDA’s. The former is under the U.S. Read the rest…

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STAT+: FDA is still struggling to inspect clinical research sites, watchdog finds

STAT

By comparison, the FDA inspected 976 clinical study sites in 2017. And the FDA was unable to complete about 30% of one type of common inspection within the requested time frames from fiscal year 2018 through July 2023.

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STAT+: Otsuka’s digital treatment for depression cleared by FDA, as pharma tries to crack tricky market

STAT

Rejoyn has been in development since 2018 and Otsuka is the first drug company to receive FDA clearance for a digital treatment for a mental health condition. ” Patients also receive cognitive behavioral therapy.

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STAT+: Why FDA product recalls have spiked in recent years

STAT

Whichever the case, product recalls by the Food and Drug Administration and the Consumer Product Safety Commission (CPSC) more than doubled between 2018 and 2022, according to new research published on Wednesday by life sciences software company MasterControl. The higher volume of recalls can mostly be attributed to the FDA.

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FDA approves Zepbound for weight loss

The Checkup by Singlecare

Food and Drug Administration (FDA) just approved Zepbound (tirzepatide) for chronic weight management. The injectable medication is a new version of Eli Lilly’s Mounjaro, which is approved by the FDA to control blood sugar in people with Type 2 diabetes. Zepbound, on the other hand, has been FDA-approved for weight loss.

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FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024

PharmaVoice

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.

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