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Hahn Should Tell Truth or Resign: Topol

[ Price : $8.95]

Scripps Research Translational Institute director Eric Topol writes an open letter to FDA commissioner Stephen Hahn asking him to ...

Dont Let Orange Book Block Competition: 23 AGs

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Twenty-three attorneys general ask FDA not to allow branded drug companies to list device and component patents in the Orange Book...

Guide on Device Patient-reported Outcomes Usage

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Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapti...

OMB Approves Eight Information Collections

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Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.

FDA Releases Draft Bioequivalence ANDA Guides

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on the design of bioequ...

FDA Approves Innocoll NDA for Xaracoll

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FDA approves an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up t...

Medical Group Petitions for Contrast Agent Warning Removal

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International Contrast Ultrasound Society petitions FDA to remove Boxed Warnings from ultrasound contrast agents.

Medtronic Pediatric Hybrid Diabetes Device Approved

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FDA approves Medtronics MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically mon...

Baxter De Novo Granted for Theranova Dialysis Membrane

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FDA grants Baxter International a de novo application for the Theranova dialysis membrane.

FDA May Give EUA for Covid Vaccine on Early Data: Hahn

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FDA commissioner Stephen Hahn says it is possible that an emergency use authorization for a Covid-19 vaccine could be granted befo...