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 Gottlieb Wants to Stay at FDA
10/11/2017
 
 
TXT FDA Expediting Reviews/Approvals to Prevent Shortages After Hurricanes
10/13/2017
 
 
TXT Philips to Halt Defibrillator Manufacturing Under Consent Decree
10/11/2017
 
 
TXT Draft REMS Document Format Guidance Out
10/11/2017
 
 
TXT FDA Updates ‘Least Burdensome’ Guidance
10/12/2017
 
 
TXT Healthcare Technology Safety Bill Introduced
10/10/2017
 
 
TXT Since Our Last Issue ...
10/15/2017
 
 
TXT Latest Federal Register Notices
10/15/2017
 
 
TXT Product Approval Summaries
10/15/2017
 
 
TXT MDIC Releases IVD Surrogate Sample Framework
10/13/2017
 
 
TXT FDA Gains Consent Decree Against Supplement Maker
10/13/2017
 
 
TXT Draft Guide on Generic Drug Complete Response Meetings
10/13/2017
 
 
TXT Panel Backs Sparks Gene Therapy for Vision Loss
10/12/2017
 
 
TXT Drug Safety Data Threat Growing: PwC Report
10/12/2017
 
 
TXT PDUFA 6 User Fees Explained
10/12/2017
 
 
TXT Draft Abbreviated Approval Pathway Guidance
10/12/2017
 
 
TXT Merck Scraps NDA Filing for Cholesterol Drug
10/12/2017
 
 
TXT Guidance on GDUFA Division Reconsideration Requests
10/11/2017
 
 
TXT CMC Guidance Clarifications Sought
10/11/2017
 
 
TXT Draft Guide on Developing RSV Drugs
10/11/2017
 
 
TXT St. Jude Recalls Unify Defibrillators Over Battery Issue
10/11/2017
 
 
TXT QS and MDR Violations at Sweden’s Euro Diagnostica
10/10/2017
 
 
TXT QS Violations in Diasol Inspection
10/10/2017
 
 
TXT Novo Nordisk Asks Liraglutide Drug ANDA Restrictions
10/10/2017
 
 
TXT Pfizer Sees Potential Guidance Conflicts
10/10/2017
 
 
TXT FDA Rejects Mylan’s BLA for Neulasta Biosimilar
10/10/2017
 
 
TXT Latest FDA Warning Letters
10/10/2017
 
 
TXT FDA Awards 6 Research Grants on Natural History Studies
10/09/2017
 
 
 
 
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