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FDA-RELATED NEWS
 
 
 
TXT FDA to Help With Legislation to Curb Generic Drug Delays
09/22/2016
 
 
TXT Look at FDA Enforcement and 1st Amendment: MIWG
09/22/2016
 
 
TXT Rep. Fitzpatrick Seeks Hearing on FDA and Device Safety
09/23/2016
 
 
TXT House Committee Leaders Want OCI Update
09/21/2016
 
 
TXT CDRH Sets 10 Regulatory Science Priorities
09/20/2016
 
 
TXT FDA Policy Makes Journalist ‘Watchdogs into Lapdogs’: Analysis
09/22/2016
 
 
TXT Diabetes Drugs Riskiest to Develop: Tufts Study
09/20/2016
 
 
TXT False Advertising Claim Not Precluded by FFDCA
09/21/2016
 
 
TXT Groups Fear Weakened REMS
09/21/2016
 
 
TXT Computational Modeling Studies Reporting Guidance
09/20/2016
 
 
TXT Sherman Moves Into Califf’s Former Position
09/26/2016
 
 
TXT Since Our Last Issue ...
09/25/2016
 
 
TXT Latest Federal Register Notices
09/25/2016
 
 
TXT Product Approval Summaries
09/25/2016
 
 
TXT CGMP Violations in Hebei Yuxing Inspection
09/22/2016
 
 
TXT Generic Drug Facility Self-Identification Guidance
09/22/2016
 
 
TXT Pediatric Voucher Program Expires October 1
09/22/2016
 
 
TXT Office of Clinical Pharmacology Good Review Practices
09/22/2016
 
 
TXT FDA Lab Test Proposal is ‘Double Regulation’: Senator
09/21/2016
 
 
TXT CDER Office of Surveillance and Epidemiology MAPP
09/21/2016
 
 
TXT Adverse Events Unreported in Published Studies: Research
09/21/2016
 
 
TXT ‘Roundabout’ Causation in Failure-to-Report Claims: Attorney
09/20/2016
 
 
TXT Alcon Wants Durezol Bioequivalence Requirements
09/20/2016
 
 
TXT Latest FDA Warning Letters
09/20/2016
 
 
TXT FDA Draft Guide on Determining When REMS is Necessary
09/20/2016
 
 
TXT FDA Rescinds Teva SPA After Dosing Changed
09/19/2016
 
 
 
 
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