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FDA-RELATED NEWS
 
 
 
TXT FDA Quality Guide on Real World Data Coming
09/09/2019
 
 
TXT FDA Aims to Ban Flavored e-Cigarettes
09/11/2019
 
 
TXT Public Citizen Sues FDA Seeking Cesium Chloride Ban
09/10/2019
 
 
TXT FDA Biosimilar Bioanalytical ‘Best Practices’ Coming
09/13/2019
 
 
TXT Four 510(k) Guidances Out
09/12/2019
 
 
TXT FDA Denies Petition Seeking New Opioid Moratorium
09/09/2019
 
 
TXT Carcinogen NDMA Now Spreads to Heartburn Drugs
09/13/2019
 
 
TXT Courts Let Companies Keep Drug Risks Secret: Reuters
09/11/2019
 
 
TXT Suggestions for Use Instructions Guidance
09/11/2019
 
 
TXT ‘Fabulous’ Science is ‘Not Enough’: Woodcock
09/11/2019
 
 
TXT Sterigenics Sterilization Facility Temporarily Closed
09/13/2019
 
 
TXT Modeling Tool for Coronary Artery Disease Cleared
09/12/2019
 
 
TXT Some Post-Approval Studies Need a Long Time: Opinion Post
09/10/2019
 
 
TXT Ipca Laboratories FDA-483
09/10/2019
 
 
TXT 2 FDA Guidances on De Novo Device Requests
09/09/2019
 
 
TXT Latest Federal Register Notices
09/15/2019
 
 
TXT Since Our Last Issue ...
09/15/2019
 
 
TXT Product Approval Summaries
09/15/2019
 
 
TXT Warning on CDK 4/6 Inhibitors Lung Condition
09/13/2019
 
 
TXT Advisory Panel to Discuss Vascepa sNDA
09/12/2019
 
 
TXT Patent Abuse Leads to Higher Drug Prices: Column
09/12/2019
 
 
TXT FDA Clears GE Critical Care Suite
09/12/2019
 
 
TXT Treatment Effect Influences FDA Approval Decisions: Study
09/12/2019
 
 
TXT Metrix Recalls IV Flexible Bags
09/10/2019
 
 
TXT FDA Develops Hepatitis A Immune Response Biomarker
09/10/2019
 
 
TXT Abuse, Dependence Labeling Comments
09/10/2019
 
 
TXT CluePoints, FDA Clinical Trial Site Selection Model
09/10/2019
 
 
TXT Hangzhou Badi CGMP Violations
09/10/2019
 
 
TXT Latest FDA Warning Letters
09/10/2019
 
 
 
 
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