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FDA-RELATED NEWS
 
 
 
TXT Woodcock Touts Medical Device Actions
07/21/2021
 
 
TXT Flexibility, Engagement are Covid Lessons for CDRH: Shuren
07/22/2021
 
 
TXT Domestic Inspections Resume Standard Operations
07/20/2021
 
 
TXT Statin Pregnancy Contraindication Lifted
07/20/2021
 
 
TXT House Committee Wants FDA Drug Inspection Info
07/22/2021
 
 
TXT Public Still Trusts FDA, CDC, Fauci: Survey
07/22/2021
 
 
TXT Field Alert Report Guidance
07/22/2021
 
 
TXT Draft Remanufacturing Guidance Falls Short: Mintz Analysis
07/21/2021
 
 
TXT FDA Approvals of High-Risk Medical Devices ‘Way Down’: Post
07/20/2021
 
 
TXT Stakeholders Urged to Transform Drug Supply Chain
07/20/2021
 
 
TXT 3 More Former FDAers Join Greenleaf Health
07/22/2021
 
 
TXT Dahlia Center Offering Cellular Product to Treat Covid-19: FDA
07/21/2021
 
 
TXT FDA Denies Professor’s Tolvaptan Petition
07/20/2021
 
 
TXT Expanded Use of Prograf Relied on RWE
07/19/2021
 
 
TXT Shift to Include Pregnant Women in Trials: FDA
07/19/2021
 
 
TXT Latest Federal Register Notices
07/25/2021
 
 
TXT Since Our Last Issue ...
07/25/2021
 
 
TXT Product Approval Summaries
07/25/2021
 
 
TXT Class 1 Recall for Philips Respironics’ Ventilators
07/23/2021
 
 
TXT Regen Centers Marketing Unapproved Cellular Products: FDA
07/22/2021
 
 
TXT FDA Not Meeting PDUFA Dates on 2 Pfizer NDAs
07/22/2021
 
 
TXT FDA Seeking New Patient Engagement Collaborative Members
07/22/2021
 
 
TXT Covis Seeks FDA Actions on Eugia Pharma ANDA
07/20/2021
 
 
TXT Ardelyx Tenapanor NDA Hits FDA Snag
07/19/2021
 
 
TXT FDA Accepts Aquestive NDA Resubmission
07/19/2021
 
 
 
 
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