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FDA-RELATED NEWS
 
 
 
TXT CLOSED FOR THE FOURTH OF JULY [46 Words]
06/25/2015
 
 
TXT FDA Says Amarin Conducting ‘Frontal Assault’ on NDA Framework [378 Words]
06/24/2015
 
 
TXT Court Nixes ‘Fraud on FDA’ Whistleblower Claim [407 Words]
06/23/2015
 
 
TXT Judge Sentences Device Company Ex-CEO to 2 Years in Jail [243 Words]
06/26/2015
 
 
TXT Since Our Last Issue ... [383 Words]
06/26/2015
 
 
TXT Product Approval Summaries [884 Words]
06/26/2015
 
 
TXT 3rd Circuit Appeals Court Broadens ‘Pay for Delay” Consideration [223 Words]
06/26/2015
 
 
TXT CBER Letter Cites ‘Unapproved’ Cell Products at BioDlogics [161 Words]
06/26/2015
 
 
TXT Wharton Paper Finds FDA Device System ‘Optimal’ [309 Words]
06/26/2015
 
 
TXT Hospira India Facility Cleared by FDA [196 Words]
06/25/2015
 
 
TXT UDI Device Marking Guidance Out [221 Words]
06/25/2015
 
 
TXT FDA Tracks Increased Essure Risks [384 Words]
06/25/2015
 
 
TXT Latest Federal Register Notices [1306 Words]
06/25/2015
 
 
TXT CBO Budget Scoring of Cures Bill Costs FDA $872 Million [261 Words]
06/24/2015
 
 
TXT Stakeholders Offer More GDUFA Policy Ideas [504 Words]
06/24/2015
 
 
TXT Excess Volume, Labeled Fill Size Guidance [300 Words]
06/24/2015
 
 
TXT FDA Looking at Role of Hearing Loss in Ads [263 Words]
06/24/2015
 
 
TXT New Ways of Improving Drug Development Profiled [299 Words]
06/24/2015
 
 
TXT Device Liability Preemption Evolving: Attorney [438 Words]
06/24/2015
 
 
TXT Physiochemical Properties Linked to Drug Safety Problems [385 Words]
06/24/2015
 
 
TXT House Bill to Allow Faster Drug Samples for Generics [120 Words]
06/23/2015
 
 
TXT Trans Ox Inspection Finds CGMP Violations [364 Words]
06/23/2015
 
 
TXT ‘Significant’ QS Violations Found at AG Industries [358 Words]
06/23/2015
 
 
TXT Latest FDA Warning Letters [307 Words]
06/23/2015
 
 
TXT WLF Brief Supports Amarin in Off-label Info Case [528 Words]
06/22/2015
 
 
TXT CA Man Pleads Guilty to Drug Diversion Scheme [131 Words]
06/22/2015
 
 
 
 
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
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