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FDA-RELATED NEWS
 
 
 
TXT Industry Veteran John Sheets Appointed ODE Director
06/22/2016
 
 
TXT Blindsided? FDA Ponders CDC’s ‘Ineffective’ Rating of FluMist
06/24/2016
 
 
TXT Report Recommends ‘Real World’ Evidence Programs for FDA
06/24/2016
 
 
TXT No New Info in Late Infuse Reports: FDA
06/23/2016
 
 
TXT Reps Say FDA Slow to Implement Lab Safety
05/19/2016
 
 
TXT Reichel Acquittal Won’t Stop DoJ: Attorneys
06/23/2016
 
 
TXT Pharmacist Group Reverses Policy to Urge DTC Ban
06/24/2016
 
 
TXT The CREATES Act: PhRMA Opposes, GPHA Supports
06/23/2016
 
 
TXT FDA Oversight Lacking with Questionable Data in Journals: Professor
06/22/2016
 
 
TXT Court Rules Against FDA in FOIA Case as Reforms Await Obama
06/22/2016
 
 
TXT Feds Argue for False Claims Act ‘Fraud in Inducement’
06/21/2016
 
 
TXT FDA Needs ‘Substantial, Timely Reform’: Foundation
06/21/2016
 
 
TXT Product Approval Summaries
06/26/2016
 
 
TXT Latest Federal Register Notices
06/26/2016
 
 
TXT Since Our Last Issue ...
06/26/2016
 
 
TXT CDER Technical Guide on Quality Metrics
06/24/2016
 
 
TXT Indian Drug Makers Want More FDA Transparency: Mylan
06/23/2016
 
 
TXT Biosimilar Case Appeal Likely Off Until October
06/23/2016
 
 
TXT Most Clinical Research is Useless: Researcher
06/23/2016
 
 
TXT FDA Supply Chain Regulations Due Soon: Attorneys
06/23/2016
 
 
TXT Avoid Medical Device Development ‘Wipeouts’: Consultant
06/22/2016
 
 
TXT Marking 40 Years of Medical Device Amendments
06/22/2016
 
 
TXT ICH Safety Report Specifications Out
06/22/2016
 
 
TXT NIH Advisors Approve CRISPR Trial
06/22/2016
 
 
TXT Change Combination Product Guidance: Stakeholders
06/22/2016
 
 
TXT FDA, EMA Form Joint Working Group on Patient Engagement
06/22/2016
 
 
TXT 2 Compounding Pharmacists Sentenced in Tainted Drugs Case
06/22/2016
 
 
TXT Elements Removed from Sabril REMS
06/22/2016
 
 
TXT CGMP Violations at Burzynski Manufacturing
06/21/2016
 
 
TXT Latest FDA Warning Letters
06/21/2016
 
 
TXT NIH Streamlines IRB Multi-Site Policy
06/21/2016
 
 
TXT QS Violations at Tyrx
06/21/2016
 
 
TXT High Court OKs ‘Broad Interpretation’ in Patent Reviews
06/21/2016
 
 
TXT FDA Yanks Notice Seeking OMB Approval on Biologic Naming
06/21/2016
 
 
TXT CDER Working on 2 Biosimilar Guidances for Release This Year
06/20/2016
 
 
 
 
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