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FDA-RELATED NEWS
 
 
 
TXT Cancer Activist Protests Trump Move on FDA Guidances
04/18/2019
 
 
TXT Too Many Cancer Immunotherapeutics Available?
04/17/2019
 
 
TXT FDA Halts Sales of Transvaginal Mesh Repair Products
04/16/2019
 
 
TXT FDA Not Heading in a New Direction: Sharpless
04/16/2019
 
 
TXT FDA Working to Harmonize Device Quality Regs: Consultants
04/17/2019
 
 
TXT PhRMA Ad Cost Info Varies: Analysis
04/17/2019
 
 
TXT Device Premarket Imaging Guidance
04/18/2019
 
 
TXT Medical Device Nitinol Assessment Guidance
04/18/2019
 
 
TXT Hi-Tech Says FDA Warning Letter is ‘Bullying’
04/17/2019
 
 
TXT Public Citizen Wants Prolia Boxed Warning
04/16/2019
 
 
TXT Latest Federal Register Notices
04/21/2019
 
 
TXT Product Approval Summaries
04/21/2019
 
 
TXT Since Our Last Issue ...
04/21/2019
 
 
TXT Teva Gains Approval for First Generic Narcan
04/19/2019
 
 
TXT Safety Concerns with Pfizer/Lilly Trial of Tanezumab
04/19/2019
 
 
TXT Bispecific Antibody Development Guidance
04/18/2019
 
 
TXT FDA Finds Sickle Cell Disease Link
04/18/2019
 
 
TXT Supreme Court May Hear Paxil Warning Case
04/18/2019
 
 
TXT Dietary Supplement Ingredients to Avoid Listing Launched
04/17/2019
 
 
TXT Workshop on Drug Analysis Data Standards Advancement
04/17/2019
 
 
TXT No Benefit in Taking Supplements: NIH Study
04/17/2019
 
 
TXT FDA Approved 2 Gene Therapies, 3 Vaccines in 2018: CBER
04/17/2019
 
 
TXT CDER Statisticians Working on Adaptive Clinical Trials
04/16/2019
 
 
TXT RIJ Pharmaceutical Inspection Finds CGMP Issues
04/16/2019
 
 
TXT Latest FDA Warning Letters
04/16/2019
 
 
TXT CGMP Violations at Malaysia’s Luen Fook Medicine
04/16/2019
 
 
TXT QuVA Pharma Cited on GMPs in Form 483
04/15/2019
 
 
TXT Gelesis’ Plenity Weight Management Capsules Cleared
04/15/2019
 
 
 
 
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