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FDA-RELATED NEWS
 
 
 
TXT FDA Order to Restrict Bayer’s Essure Use
04/09/2018
 
 
TXT Draft Guide on Expanded Abbreviated 510(k) Program
04/12/2018
 
 
TXT Final Guidance on Special Protocol Assessments
04/13/2018
 
 
TXT 2 New Genetic Disease-Based Test Guidances
04/12/2018
 
 
TXT NJ Court Hands Down $33 Million Verdict Against Bard
04/13/2018
 
 
TXT Performance Criteria for 510(k) Equivalence
04/11/2018
 
 
TXT 12 Observations in Celltrion FDA-483
04/13/2018
 
 
TXT ‘Breakthrough’ Designation Can Be Misleading: Researchers
04/12/2018
 
 
TXT Guide on Ultrasonic Diathermy Device 510(k)s
04/13/2018
 
 
TXT 4 ICH Guidances Announced
04/11/2018
 
 
TXT $2.4 Billion in Health Care Fraud Judgments, Settlements
04/11/2018
 
 
TXT Latest Federal Register Notices
04/15/2018
 
 
TXT Product Approval Summaries
04/15/2018
 
 
TXT Since Our Last Issue ...
04/15/2018
 
 
TXT FDA Probing Unauthorized Herpes Research
04/12/2018
 
 
TXT Collegium Wants Oxycodone ER Restrictions
04/11/2018
 
 
TXT 13 Observations in Alkem FDA-483

04/11/2018
 
 
TXT Innovative Health Wants NSS-2 Bridge Restrictions
04/11/2018
 
 
TXT CGMP Violations at Tris Pharma
04/10/2018
 
 
TXT Hemophilia Patient Group Asks for Hemlibra Hearing
04/10/2018
 
 
TXT Latest FDA Warning Letters
04/10/2018
 
 
TXT FDA Denies Insys’ Syndros Petition
04/10/2018
 
 
TXT FDA Issues Pediatric Guidance Addendum
04/10/2018
 
 
TXT Ultrasonics Reprocessor Validated for 2 Duodenoscopes
04/10/2018
 
 
TXT Alembic Pharmaceuticals FDA-483 Issued
04/10/2018
 
 
TXT FDA Expanded Approval for Pacira Pain Drug
04/09/2018
 
 
 
 
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