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TXT 4 Ways to Reform FDA Drug Regulatory Reform [2986 Words] [ Price : $8.95]
Former FDA principal deputy commissioner Joshua Sharfstein calls for reforms to the agency’s decades of drug regulation reform to increase the effectiveness and efficiency of the search for new therapies.
01/14/2020
 
 
TXT Personal Cancer Monitor Granted Breakthrough Status [122 Words] [ Price : $8.95]
FDA grants ArcherDX a breakthrough device designation for its Personalized Cancer Monitoring technology for early-stage cancer treatment monitoring and recurrence surveillance.
01/14/2020
 
 
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 sNDA for Lynparza Accepted for Review [247 Words] [ Price : $8.95]
FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment of certain women with advanced ovarian cancer.
01/13/2020
 
 
TXT CDER Priorities: Postmarket Safety and New Drugs Program [1205 Words] [ Price : $8.95]
CDER director Janet Woodcock says enhancing postmarket safety initiatives and modernizing the Center’s new drugs regulatory program are two of the top priorities for 2020.
01/13/2020
 
 
TXT 510(k) Preemption for Powered Wheeled Stretchers [95 Words] [ Price : $8.95]
Federal Register notice: FDA exempts powered wheeled stretchers from premarket notification (510(k)) requirements.
01/13/2020
 
 
TXT Draft Guide on PTA/Specialty Catheters [96 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.”
01/13/2020
 
 
TXT Taro Recalls 1 Lot of Contaminated Lamotrigine [127 Words] [ Price : $8.95]
Taro Pharmaceuticals recalls one lot of epilepsy/bipolar drug lamotrigine 100 mg tablets after it was found to have been cross-contaminated with a small amount of enalapril maleate.
01/13/2020
 
 
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