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FDA-RELATED NEWS
 
 
 
TXT House Commerce Committee Moves User Fee Bill to Floor Vote
05/18/2022
 
 
TXT Woodcock Assisting 7 Offices/Centers; Not Drugs/Biologics
05/19/2022
 
 
TXT House Commerce Republicans Probe China Trials
05/20/2022
 
 
TXT Drug Shortage Risk Management Guidance
05/19/2022
 
 
TXT DoJ Sues Prometheus Over Device Use
05/18/2022
 
 
TXT FDA Moving Toward Emerging Technology Regs: Kopcha
05/19/2022
 
 
TXT Bill Would Whittle Down Biologic Exclusivity
05/20/2022
 
 
TXT CDRH Device Sterility Master File Pilot
05/19/2022
 
 
TXT FDA Enterprise Modernization Plan Explained
05/19/2022
 
 
TXT Device Cybersecurity Clarifications in FDA Webinar
05/20/2022
 
 
TXT FDA Updates Philips Respironics Recall Info
05/19/2022
 
 
TXT Medical Journals Need Better Conflict Disclosures: Article
05/19/2022
 
 
TXT Dietary Supplement NDI Enforcement Discretion
05/19/2022
 
 
TXT Label Safety Considerations Guidance
05/18/2022
 
 
TXT Senate Bill to Restore FDA Orphan Drug Interpretation
05/17/2022
 
 
TXT Final Guide on Investigating Out-of-spec Results
05/16/2022
 
 
TXT Latest Federal Register Notices
05/22/2022
 
 
TXT Since Our Last Issue ...
05/22/2022
 
 
TXT Product Approval Summaries
05/22/2022
 
 
TXT Partial Clinical Hold on Leukemia Therapy
05/20/2022
 
 
TXT ISPE Wants Longer Device Quality System Implementation
05/19/2022
 
 
TXT Patel Joins Google Health
05/18/2022
 
 
TXT FDA Denies Part of Contraceptive Study Group Petition
05/18/2022
 
 
TXT AI Has Usefulness for Pharmacovigilance: Report
05/18/2022
 
 
TXT Multiple CGMP Violations at Colorful Products
05/17/2022
 
 
TXT API Deviations at Specialty Process Labs
05/17/2022
 
 
TXT Consultants Submit Draft AAV Guidance to FDA
05/17/2022
 
 
TXT Improving Trial Representation Book
05/17/2022
 
 
TXT FDA Hits Lupin’s Novel Labs with 13-item 483
05/16/2022
 
 
TXT New Home Covid Test Gives Results for Flu, RSV too
05/16/2022
 
 
 
 
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