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 Improve Accelerated Approval Process: Califf
01/20/2022
 
 
TXT Aurobino Pharma Gets 2nd Warning Letter in 15 months
01/20/2022
 
 
TXT Pazdur Mulls Accelerated Approval International Harmonization
01/21/2022
 
 
TXT Device User Fee Negotiations at Standstill
01/18/2022
 
 
TXT FDA Extends Postponement of Inspections Until 2/4
01/20/2022
 
 
TXT Policy Changes and More Enforcement Coming?
01/19/2022
 
 
TXT Catalent Belgium FDA-483
01/18/2022
 
 
TXT FDA Launches REMS Public Dashboard
01/20/2022
 
 
TXT Praise, Suggestions for Hearing Aid Rule
01/20/2022
 
 
TXT FDA Met or Exceeded Many FY 2020 User Fee Goals
01/20/2022
 
 
TXT FDA Tells Revance to Qualify New Working Cell Bank
01/19/2022
 
 
TXT Latest Federal Register Notices
01/23/2022
 
 
TXT Product Approval Summaries
01/23/2022
 
 
TXT Since Our Last Issue ...
01/23/2022
 
 
TXT Guide on Technical Specs for NASH Drug Data Sets
01/21/2022
 
 
TXT Medtronic Recalls HawkOne Atherectomy System
01/21/2022
 
 
TXT FDA Lifts Hold on Kura Leukemia Trial
01/21/2022
 
 
TXT Pfizer/OPKO Complete Response on Growth Hormone
01/21/2022
 
 
TXT Mylan Recalls One Batch of Semglee Insulin
01/20/2022
 
 
TXT FDA Hold on Dyne Muscular Dystrophy IND
01/20/2022
 
 
TXT $250 Million in Counterfeit HIV Drugs Sold: Gilead
01/19/2022
 
 
TXT Getinge Recalls Vaporizer Sevoflurane Maquet Filling
01/19/2022
 
 
TXT FDA Agrees to New Nomacopan Trial Process
01/19/2022
 
 
TXT FDA Yumanity Parkinson’s Trial Hold
01/19/2022
 
 
TXT FDA Neuroscience Deputy Bastings Retires, Joins Ionis
01/19/2022
 
 
TXT Device Plan on Women’s Health Priorities
01/18/2022
 
 
TXT CGMP and QS Violations in Sunstar Inspection
01/18/2022
 
 
TXT Complex Innovative Trial Case Studies
01/18/2022
 
 
TXT CGMP Violations at South Korea’s Cosmo Bio
01/18/2022
 
 
 
 
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