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FDA-RELATED NEWS
 
 
 
TXT Gottlieb Boosts New Drug Approvals, Continuous Mfg.
11/30/2017
 
 
TXT Consultants See Industry Gains in FDA Quality Plan
11/30/2017
 
 
TXT FDA Sued Over Human Subject Protections
11/30/2017
 
 
TXT FDA Has Most of HHS Withdrawn Regulations: Survey
11/28/2017
 
 
TXT FDA Reducing Hurdles for Generic Complex Drugs: Gottlieb
11/28/2017
 
 
TXT Webinar Explains 510(k) Change Guidance
11/29/2017
 
 
TXT Mixed Decision in a Preemption Case
11/28/2017
 
 
TXT IG Faults Drug Companies’ Caring Voice Charity
11/29/2017
 
 
TXT Rep. Slaughter Urges More FDA Antibiotic Resistance Efforts
11/29/2017
 
 
TXT Since Our Last Issue ...
12/03/2017
 
 
TXT Latest Federal Register Notices
12/03/2017
 
 
TXT Product Approval Summaries
12/03/2017
 
 
TXT FDA Approves Cancer Biomarker Test
12/01/2017
 
 
TXT CDRH Webinar Explains 2 De Novo Guidances
11/30/2017
 
 
TXT Webinar Stresses Streamlined Approach to Digital Health
11/30/2017
 
 
TXT Texas Man Sentenced for Selling Unapproved Subutramine
11/30/2017
 
 
TXT FDA Worries More About Companies Than Patients: Professor
11/29/2017
 
 
TXT Regulatory Review Period Determined for Xuriden
11/29/2017
 
 
TXT Safety Alert on Biotin Affecting Lab Testing
11/28/2017
 
 
TXT Latest FDA Warning Letters
11/28/2017
 
 
TXT Dual 510(k) CLIA Waiver Guidance
11/28/2017
 
 
TXT FDA Adds Patent Submission Dates to Orange Book
11/28/2017
 
 
TXT FDA Guide on Pediatric Info in X-ray 510(k)s
11/28/2017
 
 
TXT CGMP Violations at Korea’s Dae Young Foods
11/28/2017
 
 
TXT Sentinel Role in Drug Safety Defended
11/28/2017
 
 
TXT Regeneron Not Moving Eye Drug Combo Into Phase 3
11/27/2017
 
 
TXT Draft Guide on Grandfathering Drugs Sans Product Identifiers
11/27/2017
 
 
 
 
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