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FDA-RELATED NEWS
 
 
 
TXT FDA OKs Bayer/Loxo Targeted Cancer Drug
11/27/2018
 
 
TXT FDA Efforts on Drug Shortages Told at Policy Conference
11/29/2018
 
 
TXT Former Insys VP Pleads Guilty to Racketeering
11/28/2018
 
 
TXT FDA Heading to ‘Sliding Scale’ of Medical Device Evidence: Lurie
11/27/2018
 
 
TXT FDA Plans to ‘Retire’ Outdated 510(k) Predicates
11/26/2018
 
 
TXT 2 New Blood Glucose Monitor Guidances
11/29/2018
 
 
TXT ‘Preventable Deaths’ Due to FDA: Analysis
11/27/2018
 
 
TXT NEJM Perspective Touts Sentinel Success After 10 Years
11/30/2018
 
 
TXT 4 New ICH Groups Moving Ahead
11/27/2018
 
 
TXT QS Issues at Mylan Morgantown Plant
11/27/2018
 
 
TXT GAO Faults FDA on Orphan Drug Records
11/30/2018
 
 
TXT FDA Inspection Agreements with 20 EMA Members
11/29/2018
 
 
TXT Restrictions Sought on Zelnorm sNDA
11/27/2018
 
 
TXT Discussion Document on Patient Engagement in Device Trials
11/26/2018
 
 
TXT Latest Federal Register Notices
12/02/2018
 
 
TXT Product Approval Summaries
12/02/2018
 
 
TXT Since Our Last Issue ...
12/02/2018
 
 
TXT Updated Policy on CDER Drug Shortage Management
11/30/2018
 
 
TXT Stroke Risk Safety Alert on Genzyme’s Lemtrada/Campath
11/29/2018
 
 
TXT Caregivers Missing Safety Signals on Celgene’s Idhifa
11/29/2018
 
 
TXT FDA Issues 63 Product-Specific Guidances for Generics
11/28/2018
 
 
TXT Objectionable Study Conditions at Corona Doctors Medical
11/28/2018
 
 
TXT gammaCore Nerve Stimilator Expanded for Headaches
11/28/2018
 
 
TXT CLIA Waiver Applications Update Guidance
11/28/2018
 
 
TXT Dual 510(k), CLIA Waiver Application Guidance
11/28/2018
 
 
TXT Latest FDA Warning Letters
11/27/2018
 
 
TXT Drug Post-Approval Change Guidance Comments
11/27/2018
 
 
TXT Clinical Hold Placed on Zafgen Diabetes Therapy
11/26/2018
 
 
 
 
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