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Human Drugs

Affordable Drug Manufacturing Act Reintroduced

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

Human Drugs

Trump Proposes Some Drug Imports from Canada

The Trump administration proposes allowing importation of certain prescription drugs from Canada by states, wholesalers, pharmacists, or non-federal g...

Human Drugs

FDA Gabapentinoid Safety Communication

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

Human Drugs

Is FDA Promoting Off-Label Uses?

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

FDA General

Latest FDA Warning Letters

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

Human Drugs

Generic Drug Competition Lowers Prices: FDA Analysis

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

Medical Devices

Medical Device Tax Repealed

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

Human Drugs

Reps Introduce Bill to Lower Insulin Cost

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

Human Drugs

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

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

Medical Devices

LivaNova Recalls VNS Generator System

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