Welcome to FDAweb
Pay Per View
Search our 60,748 - story database FREE
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar

 FDA Whistleblowers


<< Prev  13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Next >>
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.
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.
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Federal Register notice: FDA makes available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.”
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.
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.
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.
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.
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.
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.
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.
<< Prev  13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32  Next >>

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com