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FDA-RELATED NEWS
 
 
 
TXT When FDA Goes to Bat for One Company Against Another
04/17/2017
 
 
TXT FDA Communication Guidances Draw Comments
04/20/2017
 
 
TXT HELP Committee Pegs Vote on Gottlieb FDA Nomination
04/19/2017
 
 
TXT FDA Wants Abbott Cybersecurity Fixes
04/20/2017
 
 
TXT QbD Pilot Successes Outlined
04/20/2017
 
 
TXT Target Product Profile Benefits Education Needed: CDER
04/19/2017
 
 
TXT Aurobindo India Plant Hit With Form-483
04/19/2017
 
 
TXT FDA Denies Petition to Amend Inform Consent Documents
04/18/2017
 
 
TXT 5 Challenges for FDA Commissioner-nominee Scott Gottlieb
04/18/2017
 
 
TXT Since Our Last Issue ...
04/23/2017
 
 
TXT Latest Federal Register Notices
04/23/2017
 
 
TXT Product Approval Summaries
04/23/2017
 
 
TXT Class 1 Recall of Medtronic StrataMR Valves and Shunts
04/21/2017
 
 
TXT Bill Introduced to Speed Drug Approval After EU Action
04/21/2017
 
 
TXT FDA Adds Stronger Warning on Codeine and Tramadol
04/20/2017
 
 
TXT FDA Promoting Clinical Trial Patient Diversity: CDER
04/20/2017
 
 
TXT Pfizer Gets IV Saline Solution Probe Subpoenas
04/20/2017
 
 
TXT CDER Planning 103 New, Revised Draft Guidances in 2017
04/19/2017
 
 
TXT Government Says SCOTUS Shouldn’t Hear Decosters’ Appeal
04/19/2017
 
 
TXT Violations at ZS Pharma Listed
04/19/2017
 
 
TXT NE Compounding Center Owner Fights Fraud Claim
04/18/2017
 
 
TXT Campaign Needed to Boost Trial Enrollment: Coalition
04/18/2017
 
 
TXT Latest FDA Warning Letters
04/18/2017
 
 
TXT Topics Suggested for Combination Products Policy Council
04/18/2017
 
 
TXT FDA Class 1 Recall on Medtronic Field Action
04/18/2017
 
 
TXT St. Jude Medical Inspection’s Form-483 Released
04/17/2017
 
 
 
 
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