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Info Collection on Device Quality System Regulation

[ Price : $8.95]

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...

Academics Urge FDA to Simplify Breast Density Notifications

[ Price : $8.95]

A JAMA viewpoint article urges FDA to appropriately test for readability and general literacy its breast density notification lang...

DoJ Indictment on Unapproved Drugs

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The Department of Justice announces an indictment charging Marina Sievert (Dunedin, FL) with introducing into interstate commerce ...

Some Medical Gloves Removed From Shortage List

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FDA updates its device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC) that were in short supply due...

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program

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FDA announces a 3/28-29/2023 advisory committee meeting to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation ...

FDA Hits 2 QuVA Pharma Facilities with 483s

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FDA releases two Form FDA-483s after inspecting QuVa Pharma outsourcing facilities in New Jersey and Texas.

Dear Doctor Letters Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Improving Communication of Important Safety...

Mirati Gets Accelerated OK for Lung Cancer Drug

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FDA grants accelerated approval to Mirati Therapeutics for its Krazati (adagrasib) NDA, indicated for treating adult patients with...