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FDA-RELATED NEWS
 
 
 
TXT Gottlieb Outlines New Diagnostics Regulatory Framework
09/13/2018
 
 
TXT Trump Admin Taps Inside Counsel as Top FDA Lawyer
09/10/2018
 
 
TXT CNS Drugs Longer to Develop, Approve: Tufts Center
09/11/2018
 
 
TXT Streamlining Third-Party Device Reviews
09/13/2018
 
 
TXT Integrate Cybersecurity in Medical Device Reviews: OIG
09/11/2018
 
 
TXT PMRS Sues FDA Over Hearing on Rejected NDA
09/14/2018
 
 
TXT FDA Proposes Cutting Device Submission Copies
09/12/2018
 
 
TXT 2 Voluntary Consensus Standards Guidances
09/13/2018
 
 
TXT Ex-FDA Top Lawyer Returns to Sidley Austin
09/11/2018
 
 
TXT FDA Finds Violations in 2 Medtronic Inspections
09/11/2018
 
 
TXT FDA Making FOIA Changes in Info Regs
09/12/2018
 
 
TXT Latest Federal Register Notices
09/16/2018
 
 
TXT Since Our Last Issue ...
09/16/2018
 
 
TXT Product Approval Summaries
09/16/2018
 
 
TXT Safety Alert on Alcon’s CyPass Micro-Stent
09/14/2018
 
 
TXT 5 Observations from Cook Pharmica Inspection
09/13/2018
 
 
TXT Unichem Laboratories FDA-483
09/13/2018
 
 
TXT PharmD Solutions Recalls Compounded Drugs
09/13/2018
 
 
TXT Unexpected Impurity in Some Valsartan Products
09/13/2018
 
 
TXT Yuki Gosei Kogyo Inspection Observations
09/13/2018
 
 
TXT 54 Product-Specific Drug Guidances Out
09/13/2018
 
 
TXT Attorneys Analyze Medical Device Guidance ‘Flood’
09/12/2018
 
 
TXT Pediatric Medical Device Development Grants
09/12/2018
 
 
TXT FDA Issues Sun Pharmaceutical FDA-483
09/12/2018
 
 
TXT Latest FDA Warning Letters
09/11/2018
 
 
TXT CGMP Violations Found in Lernapharm Inspection
09/11/2018
 
 
TXT Comments on Draft Indications and Usage Labeling Guidance
09/11/2018
 
 
TXT ‘Procedural Deficiency’ in Lupin Tarapur Inspection
09/11/2018
 
 
TXT CGMP Violations at China’s Longwood Medicine (Beijing)
09/11/2018
 
 
TXT More Data Needed on Glaxo COPD Add-on Drug
09/10/2018
 
 
 
 
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