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Whats Behind the New LASIK Guidance?

[ Price : $8.95]

Attorney Jeffrey Shapiro says FDA appears to be trying to get LASIK laser manufacturers who have an approved PMA to submit a suppl...

Bill to Advance Pregnant/Lactating Women in Trials

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Representatives Kathy Castor (D-FL), Brian Fitzpatrick (R-PA), and Lauren Underwood (D-IL) introduce HR 9487, Advancing Safe Medic...

Assign TE Codes for All Approved Drugs: Study

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A Brookings Institution report suggests ways to speed FDA therapeutic equivalence ratings for injectable drugs approved through th...

Change Antibiotic Development Incentives: Study

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Harvard Medical School researchers call for new incentives to develop antibiotics that show added value for patients through clini...

Moderna/Merck Cancer Vaccine Meets Endpoint

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Moderna and Merck say their investigational mRNA cancer vaccine met its endpoint in a Phase 2b melanoma trial.

FDA Clears Bausch Contact Lens Rehydrating Drops

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FDA clears a Bausch + Lomb 510(k) for its Biotrue Hydration Boost Contact Lens Rehydrating drops.

Doc Group Wants FDA Probe of Musks Neuralink

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The Physicians Committee for Responsible Medicine calls on FDA to investigate possible good laboratory practice violations by Elon...

Info Collection on Device Quality System Regulation

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices: Current Good Manufacturing...

Smiths Device Correction on CADD Infusion System

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Smiths Medical sends an urgent medical device correction letter identifying two potential issues with CADD Infusion System Infusio...

CVM Sees 1% Decrease in Food Animal Antimicrobial Use

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CVM posts its 2021 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals that shows antimicrobial...