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TXT Grassley Wants Info on Unproven Procedures in Trials [2898 Words] [ Price : $8.95]
Sen. Charles Grassley asks HHS and FDA for information on a Florida stem cell clinic that conducted an unapproved clinical trial in which three patients were left blind.
04/17/2018
 
 
TXT FDA Reviewers Give Positive Report on GW Cannabidiol [2767 Words] [ Price : $8.95]
FDA medical reviewers say they see a positive risk-benefit profile in GW Pharma’s cannabdiol for treating two specific seiure syndromes in patients over age two.
04/17/2018
 
 
TXT Ultrasonic Diathermy Devices Policy Clarification [101 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff.”
04/17/2018
 
 
TXT Draft Guide on Streamlined Approach for Oncology IVDs [112 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.”
04/17/2018
 
 
TXT Guide on Special Protocol Assessments [84 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled “Special Protocol Assessment (SPA)” that provides information about the procedures and general policies adopted by CDER/CBER for such assessments.
04/17/2018
 
 
TXT Gottlieb Calls for Sweeping Reorganization of CDRH [2821 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb announces a sweeping reorganization of CDRH, saying it is introducing a Medical Device Safety Action Plan focusing on five elements.
04/17/2018
 
 
TXT CGMP Violations at Hong Kong’s Luen Wah Medicine [2832 Words] [ Price : $8.95]
FDA warns Hong Kong’s Luen Wah Medicine about CGMP violations in its production of finished pharmaceuticals.
04/17/2018
 
 
TXT SynCardia MDR Violations [2722 Words] [ Price : $8.95]
FDA warns SynCardia Systems about Medical Device Reporting violations associated with production of its total artificial heart system.
04/17/2018
 
 
TXT Bill to Expedite Opioid Alternative Approval [2744 Words] [ Price : $8.95]
Four senators introduce bipartisan legislation to clarify breakthrough and accelerated approvals for novel non-opioid or non-addictive pain medications and treatments for substance abuse disorders.
04/17/2018
 
 
TXT Latest FDA Warning Letters [292 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Hanbul Cosmetics Co., Luen Wah (HK) Medicine and SynCardia Systems.
04/17/2018
 
 
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