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TXT Gottlieb Boosts New Drug Approvals, Continuous Mfg. [966 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb assures Congress that the timely implementation of the 21st Century Cures Act is one of the agency’s highest priorities, while also discussing oncology drug approval enhancements and continuous manufacturing.
11/30/2017
 
 
TXT Patients Should Benefit from Drug Discounts: PhRMA [2888 Words] [ Price : $8.95]
A PhRMA report traces how money moves through the pharmaceutical distribution system and suggests that patients should get more of the benefits from negotiated payments throughout the system.
11/30/2017
 
 
TXT Draft Guide on Dual 510(k) and CLIA Waiver [111 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.”
11/30/2017
 
 
TXT Public Hearing on Evaluating Nicotine Replacement Products [112 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 1/26/2018 public hearing on its approach to evaluating the safety and efficacy of nicotine replacement therapy products, including how they should be used and labeled.
11/30/2017
 
 
TXT Webinar Stresses Streamlined Approach to Digital Health [2809 Words] [ Price : $8.95]
CDRH associate director for digital health Bakul Patel tells a webinar on precertification that the goal is a streamlined regulatory approach for software and medical devices.
11/30/2017
 
 
TXT FDA OKs Earhook Addition to Advanced Bionics Sound Processor [92 Words] [ Price : $8.95]
FDA approves an Advanced Bionics PMA supplement to add an acoustic earhook for its the Naída CI Q90 sound processor that transforms the device into a cochlear implant and hearing aid combination.
11/30/2017
 
 
TXT FDA Worries More About Companies Than Patients: Professor [3116 Words] [ Price : $8.95]
Journalism professor Charles Seife details ways in which he says FDA is withholding information about Sarepta’s Exondys 51 to protect the company.
11/29/2017
 
 
TXT Regulatory Review Period Determined for Xuriden [76 Words] [ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Wellstat Therapeutics’ Xuriden (uridine triacetate), indicated for treating hereditary orotic aciduria.
11/29/2017
 
 
TXT Merck/Pfizer Avelumab Flunks Gastric Cancer Trial [295 Words] [ Price : $8.95]
Merck KGaA and Pfizer report that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall survival with avelumab compared with physician’s choice of chemotherapy.
11/29/2017
 
 
TXT Regulatory Review Period Determined for Veltassa [74 Words] [ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Relypsa’s Veltassa (patiromer sorbitex calcium), indicated for treating hyperkalemia.
11/29/2017
 
 
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