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FDA-RELATED NEWS
 
 
 
TXT NYT to FDA: Abolish 510(k), Fix other Device Loopholes
05/06/2019
 
 
TXT U.S. Drug Supply is ‘Best Ever:’ CDER
05/10/2019
 
 
TXT TV Ad Drug Price Rule Finalized
05/08/2019
 
 
TXT SCOTUS Decision Could Increase False Claims Cases: Report
05/09/2019
 
 
TXT Drug, Medical Device Recalls Down
05/07/2019
 
 
TXT Real-World Evidence Submission Guidance
05/08/2019
 
 
TXT J&J Settles Metal Hip Cases for $1 Billion
05/08/2019
 
 
TXT House Passes 2 Bills on Orange and Purple Books
05/08/2019
 
 
TXT Oncology Drug Reproductive Toxicity Testing Guidance
05/09/2019
 
 
TXT Comments on Nonproprietary Biologic Naming
05/08/2019
 
 
TXT DTC Accelerated Approval Disclosure Study
05/07/2019
 
 
TXT Companies Using Drug Development AI: Tufts Survey
05/07/2019
 
 
TXT Latest Federal Register Notices
05/12/2019
 
 
TXT Product Approval Summaries
05/12/2019
 
 
TXT Since Our Last Issue ...
05/12/2019
 
 
TXT Medical Device Safety Act Reintroduced
05/10/2019
 
 
TXT Biosimilar Interchangeability Final Guidance
05/10/2019
 
 
TXT PhRMA Wants Combination Product Guidance Clarified
05/09/2019
 
 
TXT ICH Guideline for Clinical Study Considerations
05/09/2019
 
 
TXT Abandon FDA Biologic Naming Plan: FTC
05/09/2019
 
 
TXT Maximal Usage Trial Monograph Guidance
05/09/2019
 
 
TXT ANDA vs. 505(b)(2) Determination Guidance
05/09/2019
 
 
TXT FDA Draft Guidances on Drugs in Pregnancy, Lactation
05/08/2019
 
 
TXT FDA Releases Immunomedics EIR
05/08/2019
 
 
TXT FDA Weighing Certification of AI Devices That Learn: Report
05/07/2019
 
 
TXT Torrent Pharmaceuticals FDA-483 Out
05/07/2019
 
 
TXT Latest FDA Warning Letter
05/07/2019
 
 
TXT CGMP Issues in Laboratoires Clarins Inspection
05/07/2019
 
 
TXT Alert on Medtronic Pacemakers Due to Battery Drainage
05/07/2019
 
 
TXT Guidance on Device Q-Submission Program
05/06/2019
 
 
 
 
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