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FDA-RELATED NEWS
 
 
 
TXT Real World Evidence on Definitions Under Development: Gottlieb
09/19/2017
 
 
TXT Aegerion Pharma Pleading Guilty to Violating REMS
09/22/2017
 
 
TXT Lawyer Faults ‘New’ FDA Approach to 510(k)s
09/21/2017
 
 
TXT FDA Clears Revamped Pentax Duodenoscope
09/20/2017
 
 
TXT Researchers Urge Better FDA Monitoring of Post-approval Studies
09/22/2017
 
 
TXT Rep. Paulsen Calls for FDA Reforms
09/18/2017
 
 
TXT 5th Circuit Backs Solvay False Claims Case Dismissal
09/21/2017
 
 
TXT Analytical Similarity Statistical Guidance Out
09/21/2017
 
 
TXT Safety Alert Issued on Intercept’s Ocaliva
09/21/2017
 
 
TXT Diverse Views on Waxman-Hatch Balance
09/20/2017
 
 
TXT Pfizer Says J&J Illegally Blocking Remicade Competition
09/20/2017
 
 
TXT Concerns Raised with FDA Priority Submissions Guidance
09/19/2017
 
 
TXT Product Approval Summaries
09/24/2017
 
 
TXT Since Our Last Issue ...
09/24/2017
 
 
TXT Latest Federal Register Notices
09/24/2017
 
 
TXT FDA ‘Complete Response’ on Janssen Arthritis BLA
09/22/2017
 
 
TXT Public Citizen Sues FDA to Force Benzocaine Ruling
09/21/2017
 
 
TXT FDA Warns of Medication-Assisted Treatment Drug Risks
09/20/2017
 
 
TXT FDA Warns 13 Web Firms re Unlawful Drug Sales
09/20/2017
 
 
TXT FDA Backs Use of Opioid Addiction Drugs Despite Risks
09/20/2017
 
 
TXT FDA Panel to Review Resubmitted Testosterone NDA
09/20/2017
 
 
TXT FDA Denies BI Petition to Block GSK Trelegy Ellipta
09/19/2017
 
 
TXT Medical Device Inspection Changes in Reauthorization
09/19/2017
 
 
TXT CGMP Violations at Korea’s Firson Company
09/19/2017
 
 
TXT Wuxi Medical CGMP Violations Found
09/19/2017
 
 
TXT Pull Propecia and Generics from Market: Foundation
09/19/2017
 
 
TXT FDA Concerns with PD-1/PD-L1 Inhibitors Spread to Roche Studies
09/18/2017
 
 
 
 
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