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FDA-RELATED NEWS
 
 
 
TXT Gap Between Drug Approval and Clinical Needs: Study
10/13/2020
 
 
TXT Don’t Expect Much from New Drug Import Programs: Analysis
10/13/2020
 
 
TXT FDA Exploring Live Video Inspections During Covid
10/16/2020
 
 
TXT FDA Hides Product Names in Serious CAERS Reports: Survey
10/15/2020
 
 
TXT Many AI/ML Framework Comments Lack Evidence: Study
10/15/2020
 
 
TXT Lilly Covid Plant Fails FDA Reinspection
10/14/2020
 
 
TXT Pfizer CEO Predicts Covid Vaccine EUA Filing in November
10/16/2020
 
 
TXT Require Better De Novo Evidence: Researchers
10/13/2020
 
 
TXT AstraZeneca Vaccine Safety Info Slow Coming to FDA: Report
10/15/2020
 
 
TXT Merit Medical Paying $18 Million to Resolve Kickback Case
10/15/2020
 
 
TXT Former FDA Spokeswoman Lands as Chief of Staff Advisor
10/15/2020
 
 
TXT Labeling Carve-Out Court Decision Explained
10/14/2020
 
 
TXT Janssen Covid Vaccine Trial Paused Over Unexplained Illness
10/13/2020
 
 
TXT Since Our Last Issue ...
10/18/2020
 
 
TXT Latest Federal Register Notices
10/18/2020
 
 
TXT Product Approval Summaries
10/18/2020
 
 
TXT Two Ex-Supplement Marketers Sentenced to Prison
10/16/2020
 
 
TXT CDRH Pioritized Guidance Listing for FY 2021
10/16/2020
 
 
TXT Avoid NSAIDs in Pregnancy After 20 Weeks: FDA
10/15/2020
 
 
TXT Guide on IVD Biotin Interference Testing
10/15/2020
 
 
TXT Technical Suggestions on FDA Myeloid Leukemia Guidance
10/14/2020
 
 
TXT FDA Warns Makers of Supplements with Cesium Chloride
10/14/2020
 
 
TXT Draft Guide on Biocompatibility of Devices Contacting Skin
10/14/2020
 
 
TXT Clinical Hold on Voyager Therapeutics Gene Therapy
10/13/2020
 
 
TXT Haloderm Marketing Unapproved New Drugs: FDA
10/13/2020
 
 
TXT NIH Pauses Lilly Covid Antibody Trial
10/13/2020
 
 
TXT Latest FDA Warning Letters
10/13/2020
 
 
TXT Edge Pharma Gets 17-page Form 483
10/12/2020
 
 
 
 
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