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Affordable Drug Manufacturing Act Reintroduced

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Legislators reintroduce the Affordable Drug Manufacturing Act to help lower drug costs.

Trump Proposes Some Drug Imports from Canada

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The Trump administration proposes allowing importation of certain prescription drugs from Canada by states, wholesalers, pharmacis...

FDA Gabapentinoid Safety Communication

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FDA says patients with respiratory risk factors may be at risk for serious breathing difficulties if they use any of the gabepenti...

Is FDA Promoting Off-Label Uses?

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Attorney James Beck says FDA is breaking with long-established practice to encourage truthful promotion to doctors of off-label us...

Latest FDA Warning Letters

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FDA Webview posts summaries of the FDA Warning Letters released during our holiday break.

Generic Drug Competition Lowers Prices: FDA Analysis

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An updated FDA analysis shows that an increase in generic drug competition leads to a decrease in generic drug prices.

Medical Device Tax Repealed

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A $1.4 trillion federal spending bill includes repeal of the medical device tax imposed under the Affordable Care Act and other pr...

Reps Introduce Bill to Lower Insulin Cost

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Bipartisan House members introduce legislation they say will lower insulin costs.

CDER Approves 48 Drugs in 2019; 20% Less Than 2018

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CDER approves 48 new molecular entities in 2019, which is 20% below last years record 59 submissions.

LivaNova Recalls VNS Generator System

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LivaNova recalls (Class 1) its VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to sto...