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Guide on Device Fee Reduction for Small Businesses

[ Price : $8.95]

FDA releases a guidance entitled: Medical Device User Fee Small Business Qualification and Certification.

Safety Alert on Antibiotic Azithromycin

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An FDA safety alert warns that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain in...

PharmaMar Gains Orphan Status for Lung Cancer Therapy

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FDA grants PharmaMar an orphan drug designation for lurbinectedin and its use in treating small cell lung cancer.

FDA Aims to Accelerate Nicotine Replacement Therapy Drugs

[ Price : $8.95]

FDA commissioner Scott Gottlieb says the agency is prioritizing its efforts to help product developers bring novel nicotine replac...

Info Collection Extension Device Recall Authority

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Federal Register notice: FDA submits to OMB an information collection extension for Medical Device Recall Authority (OMB Control N...

Workshop on Advancing Pediatric Pharmacovigilance

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Federal Register notice: FDA announces a 9/14 public workshop entitled Advancing the Development of Pediatric Therapeutics: Advanc...

Senate Passes $159 Million FDA Spending Boost

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The Senate passes a minibus FY 2019 appropriations package that includes a $159 million (5%) boost for FDA over the FY 2018 enacte...

Emergency Use Authorization Revoked on Ebola Test

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Federal Register notice: FDA announces that it has revoked an Emergency Use Authorization issued to Zalgen Labs for the ReEBOV Ant...

Sensus Healthcare Next Gen Radiation Therapy System

[ Price : $8.95]

FDA clears a Sensus Healthcare 501(k) for its new SRT-100+, a next-generation Superficial Radiation Therapy solution, intended for...

FDA Clears Hologic Group B Strep Assay

[ Price : $8.95]

FDA clears a Hologic 510(k) for its Group B Streptococcus (GBS) assay on the Panther Fusion system.