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FDA-RELATED NEWS
 
 
 
TXT Republican Platform Pledges to Reform FDA
07/22/2016
 
 
TXT Problems in Sharing Drug Inspections with EU
07/20/2016
 
 
TXT Drug Inspection Teams Asking Reviewers’ Questions: Complaint
07/21/2016
 
 
TXT Postmarketing Oversight Still Challenges FDA: OIG
07/21/2016
 
 
TXT Stakeholder SPA Guidance Suggestions
07/21/2016
 
 
TXT FDA Denies AstraZeneca Petition to Block Crestor Generics
07/20/2016
 
 
TXT FDA Finds Consumers Have ‘Mixed Understanding’ of DTC Ads Role
07/19/2016
 
 
TXT FDA Warns Glaxo UK Active Pharmaceutical Ingredient Facility
07/19/2016
 
 
TXT Patient Perspectives Sought on Device Enforcement Actions
07/19/2016
 
 
TXT Product Approval Summaries
07/24/2016
 
 
TXT Since Our Last Issue ...
07/24/2016
 
 
TXT FDA Seeks More Data on Merck BLA for Bezlotoxumab
07/22/2016
 
 
TXT Stryker Class 1 Recall of Angiographic Catheter
07/22/2016
 
 
TXT FDA Unlikely to Follow Court’s BPCIA Implementation: Attorney
07/21/2016
 
 
TXT Court Upholds Patent Test Extrinsic Evidence
07/21/2016
 
 
TXT Consultants Share Checklist for FDA Site Inspections
07/20/2016
 
 
TXT FDA Committee Meeting Raises Biosimilar Issues
07/20/2016
 
 
TXT Complying with Electronic Record Requirements
07/20/2016
 
 
TXT Latest FDA Warning Letters
07/19/2016
 
 
TXT Oscor Cited for GMP Violations with 2 Devices
07/19/2016
 
 
TXT Sandoz Given ‘Complete Response’ on Neulasta Biosimilar
07/19/2016
 
 
TXT Off-label Promo Guidance Urged by Health Affairs
07/19/2016
 
 
TXT FDA to Take Longer to Review Orphan Drug Requests
07/18/2016
 
 
TXT New Guidance on Benefit-Risk Evaluation Reports
07/18/2016
 
 
TXT Personalized Medicine is Years Away: MIT Tech Review
07/18/2016
 
 
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