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FDA-RELATED NEWS
 
 
 
TXT Biosimilars Program About to Explode: Woodcock [571 Words]
02/04/2016
 
 
TXT High Court Decision Affects Off-label Promotion: Attorneys [702 Words]
02/05/2016
 
 
TXT Woodcock and Shkreli Share Same Witness Table at Hearing [530 Words]
02/04/2016
 
 
TXT Industry-supported Patients ‘Hijack’ FDA Meetings: Researchers [703 Words]
02/02/2016
 
 
TXT FDA-sponsored Report on Mitochondrial Replacement Techniques [741 Words]
02/03/2016
 
 
TXT FDA Move on Salmon Helps Califf Nomination [191 Words]
02/01/2016
 
 
TXT Murray Introduces Duodenoscope Bill [230 Words]
02/04/2016
 
 
TXT FDA Outlines Action Plan on Opioid Abuse [713 Words]
02/04/2016
 
 
TXT FDA Releases 2015 Enforcement Stats [146 Words]
02/04/2016
 
 
TXT Celltrion Biosimilar Headed to Panel on ‘Highly Similar’ Finding [191 Words]
02/05/2016
 
 
TXT BMJ Says Questions Raised About Califf’s Xarelto Trial [730 Words]
02/04/2016
 
 
TXT Amarin Ruling Makes Judges Regulators: Law Professor [340 Words]
02/02/2016
 
 
TXT Cancer Moonshot Initiative Aims to Spend $1 Billion [293 Words]
02/01/2016
 
 
TXT Product Approval Summaries [928 Words]
02/07/2016
 
 
TXT Since Our Last Issue ... [487 Words]
02/07/2016
 
 
TXT Latest Federal Register Notices [1258 Words]
02/07/2016
 
 
TXT Former Pfizer Exec Criticizes Cruz Drug Approval Bill [491 Words]
02/04/2016
 
 
TXT Controlling FDA Expert Opinion in Court [215 Words]
02/03/2016
 
 
TXT Depomed Wants Nucynta ER ANDAs Changed [352 Words]
02/03/2016
 
 
TXT Court Finds Boston Scientific Case Preempted [197 Words]
02/03/2016
 
 
TXT FDA Reviews Proposal Status at MDUFA 4 Meeting [129 Words]
02/03/2016
 
 
TXT ‘Industry-wide Dance’ Shapes BPCIA Framework: Attorneys [234 Words]
02/03/2016
 
 
TXT 2 Human Factors Medical Device Guidances Out [198 Words]
02/02/2016
 
 
TXT Latest FDA Warning Letters [555 Words]
02/02/2016
 
 
TXT Positive Ad Images Affect View of Drugs: Study [234 Words]
02/02/2016
 
 
TXT CDRH Improving Premarket Reviews: Consultant [270 Words]
02/02/2016
 
 
TXT FDA Not Enforcing NDC Codes for Some Devices [113 Words]
02/02/2016
 
 
TXT Researchers Review Drug Anti-counterfeiting Safeguard [225 Words]
02/01/2016
 
 
TXT FDA Warns India’s Ipca Labs Over GMPs at 3 Plants [209 Words]
02/01/2016
 
 
TXT CDER Urges Drug Makers to Improve Technology [310 Words]
02/01/2016
 
 
 
 
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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