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Human Drugs

FDA Seeks End to Dog Use in Clinical Trials

FDA seeks to eliminate the use of dogs in clinical research by animal drug developers.

Medical Devices

All Devices Should Be Unavoidably Unsafe: Attorneys

Three King & Spalding attorneys say the Utah Supreme Court should declare that all medical devices are covered by an unavoidably unsafe tort exception...

Human Drugs

AMA Backs Some Canadian Drug Imports

The American Medical Association adopts policy to support personal importation of prescription drugs from licensed Canadian brick-and-mortar pharmacie...

Federal Register

FDA Public Meetings on e-Adverse Event Reports

Federal Register notice: FDA announces three public meetings entitled Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting Sy...

Federal Register

Proposal to Allow Informed Consent Exceptions

Federal Register proposed rule: FDA proposes to amend its regulations to implement a provision of the 21st Century Cures Act that would allow an excep...

Medical Devices

Oscor Expands TB Pacing Lead Recall

FDA says Oscor has expanded the time period covered in its recall of TB pacing leads to ensure proper disposition of expired units.

Human Drugs

Breakthrough Designation for Seattle Genetics Adcetris

FDA grants Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large c...

Medical Devices

FDA Says GE Millennium System Recall Class 1

FDA says a GE Healthcare recall of Millennium nuclear medicine imaging systems is Class 1.

Human Drugs

More FDA Biosimilar Support Needed: Novartis

Novartis says FDA and HHS could do more to counter false information about and promote increased use of biosimilars and interchangeable biologic produ...

Human Drugs

Using Social Media for Drug Use Trends

CDER Office of Communications associate director Paula Rausch describes how FDA monitors social media and online conversations as a first step in deve...