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TXT Machine Learning Increasingly Important to FDA [2699 Words] [ Price : $8.95]
FDA staffers discuss the future role of machine learning in drug development and regulation.
01/15/2020
 
 
TXT FDA Device Warning Letters May Increase: Keith [2852 Words] [ Price : $8.95]
CDRH associate director Erin Keith says the Center will be issuing more Warning Letters now that staff are getting used to an internal reorganization.
01/15/2020
 
 
TXT Republicans Reopen Opioid Manufacturer Probe [2709 Words] [ Price : $8.95]
House Energy and Commerce Committee Republican leaders say they are renewing a 2018 investigation into three opioid manufacturers to get all the information and answers they are seeking.
01/14/2020
 
 
TXT FDA Alert on Eisai Weight-loss Drug [100 Words] [ Price : $8.95]
A new FDA safety alert says that results from a clinical trial assessing safety of Eisai’s weight-loss drugs Belviq and Belviq XR (lorcaserin) show a possible increased cancer risk.
01/14/2020
 
 
TXT Partial Clinical Hold on Innate’s Lacutamab [293 Words] [ Price : $8.95]
FDA places a partial clinical hold on Innate Pharma’s TELLOMAK Phase 2 trial that is evaluating lacutamab’s efficacy and safety in patients with advanced T-cell lymphomas.
01/14/2020
 
 
TXT Expedited Review Doesn’t Cut Development Time: Study [2865 Words] [ Price : $8.95]
Harvard Medical School researchers say it is difficult to determine whether FDA expedited drug review and approval programs have actually incentivized greater therapeutic innovation.
01/14/2020
 
 
TXT BioCardia Deflectable Guide Catheter Cleared [105 Words] [ Price : $8.95]
FDA clears a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart.
01/14/2020
 
 
TXT Production and Process Controls Learning Module [2712 Words] [ Price : $8.95]
CDRH consumer safety officer Vidya Gopal uses a Webcast to describe requirements in the production and process controls subsystem.
01/14/2020
 
 
TXT FDA, NIH Not Enforcing Clinical Trial Reporting: Report [3015 Words] [ Price : $8.95]
A Science investigative report details the large percentage of clinical trials that fail to meet legal requirements for submitting data and results and have not been subject to FDA or NIH enforcement action.
01/14/2020
 
 
TXT CGMP Violations at Health Pharma [2833 Words] [ Price : $8.95]
FDA warns Health Pharma about CGMP violations in its work as a contract manufacturer of finished drugs.
01/14/2020
 
 
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