HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 62,850 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>
 
TXT 2 Guidances to Help Modernize Clinical Trials [565 Words] [ Price : $8.95]
As part of its continuing push to modernize clinical trials, FDA posts two guidance documents to provide greater clarity and recommendation for drug developers.
10/15/2018
 
 
TXT PhRMA DTC Pricing Effort Aims to Stave Off Regulations [411 Words] [ Price : $8.95]
Presumably to avert new FDA regulations about adding price information in direct-to-consumer ads, Pharmaceutical Research and Manufacturers of America modifies its existing voluntary DTC principles to require member companies to include ways to find such information in their television ads.
10/15/2018
 
 
TXT FDA Draft Guide on Rare Disease Pre-IND Meetings [65 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.”
10/15/2018
 
 
TXT Class 1 Recall for Endologicx Endovascular AAA Device [199 Words] [ Price : $8.95]
FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdominal aortic aneurysm] System and the risks associated with Type III endoleaks.
10/15/2018
 
 
TXT Civco Radiotherapy for Immobilization System [71 Words] [ Price : $8.95]
FDA clears a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System.
10/15/2018
 
 
TXT Untitled Letter on Web Site Product Promotion [167 Words] [ Price : $8.95]
CBER sends an untitled letter to the operator of two Web sites — http://www.ollereg.com and http://www.innovativeallergy.com — because they were promoting an unapproved product, Ollereg Oral Immunotherapy.
10/15/2018
 
 
TXT FDA Approves EyePoint Pharma Uveitis Drug [116 Words] [ Price : $8.95]
FDA approves EyePoint Pharmaceuticals’ Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uveitis affecting the posterior segment of the eye.
10/15/2018
 
 
TXT Guide on Revised ‘Common Rule’ Implications [175 Words] [ Price : $8.95]
FDA posts a guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”
10/12/2018
 
 
TXT Notice on Pathogen Reduction Workshop Corrected [81 Words] [ Price : $8.95]
Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.”
10/12/2018
 
 
TXT Grifols Test OK’d for Blood Group Genotyping [107 Words] [ Price : $8.95]
FDA approves Grifols’ ID Core XT molecular diagnostic test for blood group genotyping.
10/12/2018
 
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>
 

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