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Meeting on FDA Hiring/Retention Report

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Federal Register notice: FDA announces a 3/15 virtual meeting entitled FDA Hiring and Retention Final Assessment and an opportunit...

FDA Debars Parks for 5 Years on Unapproved Drug

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Federal Register notice: FDA debars Brian Michael Parks for five years from importing or offering for import any article of food (...

FDA Challenges Denali Toxicology Assessment on Alzheimer's Drug

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FDA takes issue with Denali Therapeutics preclinical toxicology assessment and requests changes to the clinical trial protocol, th...

Spectrum NDA Accepted for HER2 Lung Cancer

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FDA accepts for review a Spectrum Pharmaceuticals NDA for poziotinib and its use in treating patients with previously treated loca...

OGD Approved 100 Competitive ANDAs in 2021

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CDERs Office of Generic Drugs says it approved 100-designated Competitive Generic Therapy ANDAs in 2021 for products recognized as...

ProQR Trial in Eye Disease Fails

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A pivotal Phase 2-3 trial (Illuminate) evaluating ProQR Therapeutics sepofarsen for treating genetic eye disease CEP290-mediated L...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 2/11/2022.

Spore Test Strip Put Into Class 2

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Federal Register notice: FDA classifies the spore test strip into medical device Class 2 (special controls).

Class 2 for Predictive Cardiovascular Indicator

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Federal Register notice: FDA classifies the adjunctive predictive cardiovascular indicator into medical device Class 2 (special co...

Senseonics Continuous Glucose Monitor Approved

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FDA approves a Senseonics Holdings next-generation Eversense E3 continuous glucose monitoring system and its use for up to six mon...