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FDA-RELATED NEWS
 
 
 
TXT Senate Unveils User Fee Reauthorization Bill With FDA Enhancements
05/27/2022
 
 
TXT Groups Want Stronger Post-Market Trial Enforcement
05/24/2022
 
 
TXT Drug Importation Small Entity Q&A
05/25/2022
 
 
TXT BLOCKING Act Would Hurt Generic Drug Access: Attorneys
05/25/2022
 
 
TXT Value Seen in Joint GCP Inspections
05/25/2022
 
 
TXT FDA Denies ICAN Petition on J&J Covid Vaccine
05/26/2022
 
 
TXT FDA ‘Irresponsible’ in NIPT Safety Warning: Attorneys
05/25/2022
 
 
TXT Researchers See Breakthrough Therapy Value in Cancer
05/26/2022
 
 
TXT Vanda Sues FDA to Overturn Fast Track Rejection
05/24/2022
 
 
TXT Aurobindo Pharma FDA-483
05/24/2022
 
 
TXT Revise Dietary Supplement Listing Bill: Researchers
05/25/2022
 
 
TXT Manchin, Braun Introduce Opioids Superiority Bill
05/26/2022
 
 
TXT Former Doctor, Sales Rep Guilty in Fraud Case
05/25/2022
 
 
TXT Groups Suggest Changes to Device Quality System Reg
05/24/2022
 
 
TXT Antibacterial Therapy Q&A Guidance
05/24/2022
 
 
TXT Companies Push New Formulations for Blockbusters
05/23/2022
 
 
TXT Guide on Renal Cell Carcinoma Drug Development
06/28/2022
 
 
TXT OTC Drug Proposal to Offer New Class of Products
06/27/2022
 
 
TXT Since Our Last Issue ...
05/30/2022
 
 
TXT Product Approval Summaries
05/30/2022
 
 
TXT Latest Federal Register Notices
05/30/2022
 
 
TXT FDA Approves Medtronic In.Pact 018 Balloon Catheter
05/27/2022
 
 
TXT OTC External Analgesic Product Labeling Petition
05/26/2022
 
 
TXT CRL for Verrica Molluscum Drug
05/25/2022
 
 
TXT FDA Refuses to File Nymox Pharma NDA
05/24/2022
 
 
TXT CSL Behring BLA for Hemophilia B Gene Therapy
05/24/2022
 
 
TXT More Women Participating in Clinical Trials: Report
05/23/2022
 
 
TXT FDAers Discuss PBBM Overview and Future
05/23/2022
 
 
TXT Companies Say Pfizer Covid Booster Effective in Young Kids
05/23/2022
 
 
TXT EMA Recommends Suspending Generics Tested by Synchron
05/23/2022
 
 
TXT FDA Denies Tyvaso DPI Petition
05/23/2022
 
 
TXT Warning on Genetic Prenatal Screening Tests
05/23/2022
 
 
 
 
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