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FDA-RELATED NEWS
 
 
 
TXT Drop in FDA Enforcement Noted
07/08/2019
 
 
TXT Grassley, Durbin Want Ad Drug Prices
07/10/2019
 
 
TXT Reckitt Benckiser Settles Suboxone Marketing Cases for $1.4 Billion
07/11/2019
 
 
TXT FDA Recognizes All EU States Under MRA
07/11/2019
 
 
TXT Rare Disease R&D is Active Development Area: Tufts
07/09/2019
 
 
TXT FDA Releases Dr. Reddy’s FDA-483
07/09/2019
 
 
TXT Population Pharmacokinetics Draft Guidance
07/11/2019
 
 
TXT Hormonal Drug Effectiveness, Safety Guidance
07/11/2019
 
 
TXT Pennsylvania Courts Assess Medical Device Strict Liability
07/11/2019
 
 
TXT Latest Federal Register Notices
07/14/2019
 
 
TXT Product Approval Summaries
07/14/2019
 
 
TXT Since Our Last Issue ...
07/14/2019
 
 
TXT Altaire Recalls OTC Eye Drops
07/12/2019
 
 
TXT Warning Letter Issued After IRB Inspection
07/12/2019
 
 
TXT GE Healthcare Recalls Infant Warmers
07/12/2019
 
 
TXT Omeros, FDA Agree on Narsoplimab Primary Endpoint
07/11/2019
 
 
TXT FDA Qualifies Device Assessment Model Tool
07/11/2019
 
 
TXT Medicare Part D Opioid Use Down: OIG
07/10/2019
 
 
TXT Apokyn ANDAs Should Cover Drug and Device Parts: Petition
07/10/2019
 
 
TXT 2 DoJ Whistleblower Policies Explained
07/10/2019
 
 
TXT 2 Guidances to Speed Generic Drug Development
07/10/2019
 
 
TXT Live Case Presentations in Device Trials Guide
07/10/2019
 
 
TXT Remove Amarin Corp. Patent from Orange Book: Petition
07/10/2019
 
 
TXT Leverage Facebook Health Support Groups: CMI/Compas
07/10/2019
 
 
TXT Quality System Violations in Clinicon Inspection
07/09/2019
 
 
TXT Latest FDA Warning Letters
07/09/2019
 
 
TXT FDA Prioritizing Review of ANDAs to Treat Opioid Overdose
07/08/2019
 
 
 
 
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