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Duodenoscopes Higher-than-expected Contamination Rates: FDA

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FDA issues a safety communication on reprocessed duodenoscopes after interim study results show higher-than-expected contamination...

Temple Adds New Drugs Senior Advisor Hat to Responsibilities

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CDER deputy Center director for clinical science Bob Temple accepts a new position at the Center Office of New Drugs senior advis...

Procedural Observations in FDA Lupin Inspection

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Indias Lupin Pharmaceuticals says FDA wrote up only "procedural" observations at three of its Mandideep generic drug manufacturing...

Genentech Tecentriq Combo Use OKd for Lung Cancer

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FDA approves Genentechs Tecentriq (atezolizumab) for combination use with Avastin (bevacizumab), paclitaxel and carboplatin (chemo...

iCAD Cancer Detection Software Cleared

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FDA clears an iCAD Inc. 510(k) for its ProFound AI, a cancer detection software solution for digital breast tomosynthesis that rel...

Alert on Sterile Drugs from Promise Pharmacy

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FDA says health care professionals and patients should not to use drug products intended to be sterile that were produced by Promi...

Comments Sought on Real World Evidence Program

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Federal Register notice: FDA seeks comments on a CDER/CBER framework for implementing a program to evaluate the potential use of r...

Proposed Rule on De Novo Classification Process

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Federal Register proposed rule: FDA proposes to establish requirements for its medical device De Novo classification process.

Draft Guide on Companion Diagnostics

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Federal Register notice: FDA makes available a draft guidance entitled Developing and Labeling In Vitro Companion Diagnostic Devic...

AbbVie Stops Enrollment in Rova-T Study

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AbbVie stops enrollment in the TAHOE trial, a Phase 3 study evaluating rovalpituzumab tesirine as a second-line therapy for advanc...