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TXT Mammography Quality Assurance Advisory Panel Renewal [71 Words] [ Price : $8.95]
Federal Register notice: FDA renews the National Mammography Quality Assurance Advisory Committee for an additional two years.
08/13/2019
 
 
TXT Comments Sought on Device Q-Submission Program [91 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for its “Q-Submission Program for Medical Devices” (OMB Control Number 0910-0756).
08/13/2019
 
 
TXT Revised Guide Gastroparesis Drug Development [102 Words] [ Price : $8.95]
FDA revises a 2015 draft guidance on “Gastroparesis: Clinical Evaluation of Drugs for Treatment.”
08/13/2019
 
 
TXT Info Collection Extension for Device Accessories [84 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for its guidance on medical device accessories.
08/13/2019
 
 
TXT Drug Recalls Down, Units Up [2918 Words] [ Price : $8.95]
The Stericycle Recall Index says drug recalls are dropping but the number of recalled units is increasing, while medical device recalls and units are dropping.
08/13/2019
 
 
TXT FDA Inactivating Some Drug Listing Records [2825 Words] [ Price : $8.95]
FDA says it will start inactivating drug listing records that are improperly listed according to agency requirements.
08/13/2019
 
 
TXT QS Violations in Talon Inspection [2953 Words] [ Price : $8.95]
FDA warns Talon about Quality System and other violations in its production of Class 1 and 2 medical devices.
08/13/2019
 
 
TXT CGMP Violation in Emcure Inspection [2859 Words] [ Price : $8.95]
FDA warns India’s Emcure Pharmaceuticals about a CGMP issue in its production of finished pharmaceuticals.
08/13/2019
 
 
TXT No Higher Prostate Cancer Risk with Entacapone [2695 Words] [ Price : $8.95]
FDA says further study has indicated no increased risk of prostate cancer for users of Comtan or Stalevo to treat Parkinson’s disease.
08/13/2019
 
 
TXT FDA Resists Criticism of Postmarketing Requirements: Study [2777 Words] [ Price : $8.95]
Dalhousie University professor Matthew Herder says FDA appears resigned to and resistant to criticism of its increasing regulatory reliance on postmarketing requirements.
08/13/2019
 
 
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