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Human Drugs

Lawmakers Urge Justice Dept. to Go After Generic Firms

Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) urge the Justice Department to investigate 20 generic drug manufacturers for allegedly e...

Medical Devices

Bio-Techne Prostate Test Gets 'Breakthrough'

FDA grants Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based li...

Federal Register

Industry Reps Sought for CBER Advisory Committee

Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representative to se...

Medical Devices

Cochlear Implant OKd for Android Smartphone Streaming

FDA approves Cochlear Limiteds new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processors new built-in connectivity ...

Human Drugs

Orphan Drug Status for NuCanas Acelarin

FDA grants NuCana an orphan drug designation for its investigational drug, Acelarin (NUC-1031), and its use in treating biliary tract cancer.

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 6/14/2019.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Advanced Botanical Consulting and Testing, Spectrum Laboratory Products and Vida Intern...

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 6/14/2019.

Human Drugs

Revised Guide on ANDA Submissions

FDA revises its guidance on ANDA Submissions Content and Format.

Medical Devices

Amalgam Concerns Flood Patient Info Docket

Patients and consumers worried about dental amalgams mercury content and its risks flood an FDA docket seeking input on Patient Preference Information...