FDA Webview Site FDA Review Site FDA Updater Site
header.gif
Username:
Password:
 

human drugs
animal drugs
biologics
eirs 483s
medical devices
marketing
email
search our site
  
FDA-RELATED NEWS
 
 
 
TXT Pew: Restore FDA Oversight of Lab-developed Tests
04/29/2021
 
 
TXT 2 Bills Affecting FDA Signed Into Law
04/26/2021
 
 
TXT FDA Should Require Better Cancer Drug Trial Representation: Study
04/29/2021
 
 
TXT FDA/HHS Withdraw Trump Policy on Drug Stats
04/30/2021
 
 
TXT 7 Topics Discussed at MDUFA 5 Reauthorization Meeting
04/28/2021
 
 
TXT 2 Bills Introduced to Speed Generic Drugs
04/30/2021
 
 
TXT Acceleron Failed to Submit Trial Results: FDA
04/28/2021
 
 
TXT AdvaMedDx Comments on FDA Viral Mutation Impact Guidance
04/29/2021
 
 
TXT Court Applies ‘Rule of Reason’ in ‘Pay-for-Delay’ Opana Case
04/27/2021
 
 
TXT Quality in 510(k) Review Pilot Ending
04/27/2021
 
 
TXT BsUFA Reauthorization Steering Committee Ground Rules Set
04/28/2021
 
 
TXT Latest Federal Register Notices
05/02/2021
 
 
TXT Since Our Last Issue ...
05/02/2021
 
 
TXT Product Approval Summaries
05/02/2021
 
 
TXT Pacific Medical Recalls Alaris Pump Front Bezel
04/30/2021
 
 
TXT Leo Dermatitis Drug Gets ‘Complete Response’
04/30/2021
 
 
TXT Drugs Prices Higher in U.S. than 3 Other Countries: GAO
04/29/2021
 
 
TXT FDA ‘Unable to Approve’ Tysabri sBLA
04/29/2021
 
 
TXT FDA Addressing TIRF REMS Recertification Concerns
04/29/2021
 
 
TXT Analysis Hits National Academy cBHT Report
04/28/2021
 
 
TXT Panel Backs Keytruda and Tecentriq in Bladder Cancer
04/28/2021
 
 
TXT Protalix Gets ‘Complete Response’ on Fabry Therapy
04/28/2021
 
 
TXT Inspection Delay Impacts Sol-Gel NDA Review
04/27/2021
 
 
TXT Antisense Oligonucleotide Nonclinical Testing Guidance
04/27/2021
 
 
TXT Erica Jefferson Returning to FDA
04/27/2021
 
 
TXT Latest FDA Warning Letters
04/27/2021
 
 
TXT FDA Lifts Clinical Hold on Huntington’s Therapy
04/26/2021
 
 
TXT Clinical Hold Lifted on UniQure Gene Therapy
04/26/2021
 
 
TXT House Hearing on Lowering Rx Drug Prices
04/26/2021
 
 
TXT Pharmacometric Models in Drug Development: FDA
04/26/2021
 
 
 
 
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