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FDA-RELATED NEWS
 
 
 
TXT Trump Nominates Alex Azar as Next HHS Secretary
11/13/2017
 
 
TXT Device Recalls Down, Drug Recalls Up in 3rd Quarter
11/08/2017
 
 
TXT FDA Wants to Reduce Companies Gaming REMS
11/08/2017
 
 
TXT FDA Hits Lupin with Warning on 2 Indian Facilities
11/09/2017
 
 
TXT Potential ‘Pay-for-Delay’ Settlements Down: Report
11/07/2017
 
 
TXT FDA Harmonizing MDR Adverse Event Coding with Other Regulators
11/10/2017
 
 
TXT False Claims Act Off-Label Promotion Case Fails
11/07/2017
 
 
TXT Ad Group Refers Synergy Claims to FTC
11/08/2017
 
 
TXT CDRH Role in Device Trial Design Should be Disclosed: JAMA
11/07/2017
 
 
TXT Insys Wants Generic Syndros Requirements
11/09/2017
 
 
TXT Drug Companies’ Greater Use of Real-World Evidence: Report
11/08/2017
 
 
TXT FDA Denies Fresenius Keryx Petition
11/08/2017
 
 
TXT Harris Probing Alkermes Vivitrol Sales
11/07/2017
 
 
TXT FDA Offers ‘Flexible’ Approach for Genetic Health Risk Tests
11/06/2017
 
 
TXT Product Approval Summaries
11/12/2017
 
 
TXT Since Our Last Issue ...
11/12/2017
 
 
TXT Latest Federal Register Notices
11/12/2017
 
 
TXT Motor Vehicle Drug Effect Guidance
11/09/2017
 
 
TXT Generic Drug Review Prioritization MAPP
11/09/2017
 
 
TXT FDA Awards Grants to Advance Pediatric Drug Studies
11/09/2017
 
 
TXT Courts Should Defer to FDA Pediatric Policy: Professor
11/08/2017
 
 
TXT FDA Denies Millennium Velcade Petition
11/07/2017
 
 
TXT FDA Lifts Clinical Hold on Cellectis UCART 123
11/07/2017
 
 
TXT Latest FDA Warning Letters
11/07/2017
 
 
TXT Guide on Recurrent Herpes Labialis Drug Development
11/07/2017
 
 
TXT ‘Objectionable Conditions’ Found at Dentist’s Clinical Site
11/07/2017
 
 
TXT CGMP Violations at Guangdong Zhanjiang Jimin
11/07/2017
 
 
 
 
The most authoritative FDA news analysis each week is found in the pages of Dickinson's FDA Review. Since 1984, this newsletter has been providing in-depth reports on the most significant FDA developments affecting the pharmaceutical, medical device, biologics and veterinary medicines industries. Unlike other media, FDA Review eliminates time-wasting minutia and presents in clear, concise language the essence of what's really important - and why. It is the publication that FDA officials themselves read. Delivered in the middle of each week, FDA Review presents:
  • The latest agency policy developments, often before they're officially announced;
  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving