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FDA-RELATED NEWS
 
 
 
TXT Public Citizen Suing FDA for Committee Member Info
04/28/2016
 
 
TXT Patients Letter to GOP Rep. Chaffetz Urges Essure Probe
04/28/2016
 
 
TXT FDA Consent Decree Against Franck Compounding Operations
04/29/2016
 
 
TXT WLF Seeks Reversal of Decision Allowing RICO Against Rx Firms
04/29/2016
 
 
TXT FDA Suggests Biosimilars Review Model in BsUFA 2
04/28/2016
 
 
TXT WLF Again Rejects Unilateral Label Changes
04/26/2016
 
 
TXT Eagle Asks Court to Force Bendeka Orphan Exclusivity
04/28/2016
 
 
TXT Industry Unhappy with Latest FDA MDUFA 4 Proposal
04/27/2016
 
 
TXT New Approach Needed on Off-label Promotion: Attorney
04/27/2016
 
 
TXT Chinese Labs Exporting New Form of Fentanyl
04/27/2016
 
 
TXT FDA ‘Complete Response’ on Digital Medicine Combo Product
04/27/2016
 
 
TXT AdvaMed Wants 1 Medical Device Cybersecurity Guidance
04/26/2016
 
 
TXT Latest Federal Register Notices
05/01/2016
 
 
TXT Since Our Last Issue ...
05/01/2016
 
 
TXT Product Approval Summaries
05/01/2016
 
 
TXT FDA Plans New Project for Emerging Genomics Technologies
04/29/2016
 
 
TXT FDA Grants Emergency Use Authorization for Quest Zika Test
04/29/2016
 
 
TXT Maloney Introduces Opioid Review Legislation
04/28/2016
 
 
TXT FDA Says Merck’s Cubicin Not Complying with PREA Study
04/28/2016
 
 
TXT FDA Expects Operational Clozapine REMS by Year-end
04/27/2016
 
 
TXT Wyeth Settles Medicaid Rebate Cases for $785 Million
04/27/2016
 
 
TXT FDA Not Considering Infection Disease Tests Properly: Groups
04/27/2016
 
 
TXT Lawmakers Concerned About Loosened Mifeprex Standards
04/27/2016
 
 
TXT FDA Tells Catalyst it Needs More Firdapse Trials
04/26/2016
 
 
TXT QS Violations Cited at Greek Device Maker
04/26/2016
 
 
TXT FDA Studying Diflucan Miscarriage Risk
04/26/2016
 
 
TXT CGMP Deviations Found in Polydrug Labs Inspection
04/26/2016
 
 
TXT Latest FDA Warning Letters
04/26/2016
 
 
TXT Guidance on Assay Development, Validation for Immunogenicity
04/25/2016
 
 
 
 
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