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FDA-RELATED NEWS
 
 
 
TXT Expedited Development, Approval in 60% of Novel Drugs
01/07/2020
 
 
TXT Petitions Increase Generic Approval Days: Study
01/08/2020
 
 
TXT Ways to Overcome Drug Company Regulatory System Abuse
01/09/2020
 
 
TXT New CDRH Tool for ’Scope Reprocessing Assurance
01/09/2020
 
 
TXT Petition Seeks to Stop FDA Enforcement on PGx Info
01/10/2020
 
 
TXT FDA, Industry Should Better Manage Device Recalls: Study
01/08/2020
 
 
TXT Much of Higher Drug Spending Not Going to Companies: PhRMA
01/09/2020
 
 
TXT Sun Pharma Gets 8-item FDA-483
01/06/2020
 
 
TXT Quality by Design Advantages Explained
01/08/2020
 
 
TXT Bayer Removes from Market 99% of Essure Devices
01/10/2020
 
 
TXT FDA Onsite Verification of Device Facility Info
01/08/2020
 
 
TXT CDER Program Helping Companies Innovate: Post
01/08/2020
 
 
TXT SCA Pharma 6-item Form 483 After Inspection
01/10/2020
 
 
TXT FDA Officials Describe Staffing Challenges
01/08/2020
 
 
TXT Teva Paying $54 Million to Settle Whistleblower Suit
01/07/2020
 
 
TXT Product Approval Summaries
01/12/2020
 
 
TXT Since Our Last Issue ...
01/12/2020
 
 
TXT Latest Federal Register Notices
01/12/2020
 
 
TXT Guide on PTA and Specialty Catheter 510(k)s
01/10/2020
 
 
TXT FDA Part of Unified Web Site for Biotechnology Regulation
01/09/2020
 
 
TXT Harvard Reseachers Ask: Why No Generics?
01/08/2020
 
 
TXT Comments on OND Opportunities, Priorities
01/08/2020
 
 
TXT Emery Pharma Wants Zantac Recalled and Sales Suspended
01/07/2020
 
 
TXT Changes Sought in Draft IND Safety Report Guidance
01/07/2020
 
 
TXT Latest FDA Warning Letter
01/07/2020
 
 
 
 
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