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FDA-RELATED NEWS
 
 
 
TXT HHS Reverses FDA Policy on Lab-Developed Tests
11/15/2021
 
 
TXT Former FDA Top Lawyer Hails RWE Advances
11/19/2021
 
 
TXT Disqualify 2 Minnesota Researchers: Public Citizen
11/17/2021
 
 
TXT FDA Article Examines ENFit Syringe Dosing Errors
11/19/2021
 
 
TXT Meeting the 510(j)(3) Reporting Requirement
11/17/2021
 
 
TXT FDA Releases EIR of Troubled Revance Facility
11/19/2021
 
 
TXT Scientists Ask How FDA Will Review New Alzheimer Drugs
11/16/2021
 
 
TXT Explore Nitrosamine Impurity Mitigation Strategies: FDA
11/18/2021
 
 
TXT Improve FDA ClinicalTrials.gov Enforcement: Researchers
11/16/2021
 
 
TXT FDA: We Need 55 Years for Pfizer Vaccine Info Request
11/18/2021
 
 
TXT Alzheimerís Treatment, Diagnostic Registry Launched
11/17/2021
 
 
TXT De Novo Granted for Virtual Reality for Pain
11/16/2021
 
 
TXT MIDD Pilot Updated
11/16/2021
 
 
TXT Upton, DeGette Introduce Cures 2.0
11/16/2021
 
 
TXT Since Our Last Issue ...
11/21/2021
 
 
TXT Latest Federal Register Notices
11/21/2021
 
 
TXT Product Approval Summaries
11/21/2021
 
 
TXT Hep C Tests Down Classified to Class 2 510(k)
11/19/2021
 
 
TXT FDA OKs Resumption of Enrollment in Masitinib Trial
11/18/2021
 
 
TXT Reminder on Leadless Pacing System Complications
11/18/2021
 
 
TXT FDA Says Its Pharmacists Can Help Consumers
11/18/2021
 
 
TXT FDA Clears Pantheris for In-stent Restinosis
11/17/2021
 
 
TXT FDA Qualifies MED Institute MRI Safety Tool
11/17/2021
 
 
TXT PhRMA Strategies to Enhance Trial Diversity
11/16/2021
 
 
TXT Changes for Electronic Submission Guidance
11/16/2021
 
 
TXT Blackrock Neurotech Breakthrough Status for Brain Interface
11/16/2021
 
 
TXT Multiple Violations at Guyer Institute
11/16/2021
 
 
TXT Revised Guide on Covid Test Transport Media
11/15/2021
 
 
TXT CBER Warns Firm on Cellular Product
11/15/2021
 
 
 
 
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