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Guide on Device Patient-reported Outcomes Usage

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapti...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

Panel Meeting on Alkermes Schizophrenia/Bipolar Drug

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Federal Register notice: FDA announces a 10/9 Advisory Committee meeting to review Alkermes NDA for schizophrenia and bipolar diso...

Guide on Device Patient-Reported Outcome Instruments

[ Price : $8.95]

FDA issues a draft guidance on patient-reported outcome instruments for use in medical device evaluations.