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FDA-RELATED NEWS
 
 
 
TXT Biden Meets with Potential FDA Head Califf
10/22/2021
 
 
TXT Sen. Blumenthal Likely to Oppose Califf Nomination
10/19/2021
 
 
TXT FY 2021 Enforcement Stats Decimated by Covid
10/20/2021
 
 
TXT CDC Panel Backs Covid Booster Vaccines
10/21/2021
 
 
TXT Real-World Data Standards Guidance
10/21/2021
 
 
TXT Revance BLA Shot Down Over Inspection Findings
10/18/2021
 
 
TXT Senators Want More Covid Vaccine Data
10/20/2021
 
 
TXT House Passes Drug Continuous Manufacturing Bill
10/20/2021
 
 
TXT OTC Hearing Aid Proposed Rule Issued
10/19/2021
 
 
TXT Boehringer’s Humira Biosimilar Now ‘Interchangeable’
10/18/2021
 
 
TXT IRB Review Needed for all IVD Studies: FDA
10/18/2021
 
 
TXT United Therapeutics Snubbed on Tyvaso DPI
10/18/2021
 
 
TXT Since Our Last Issue ...
10/24/2021
 
 
TXT Latest Federal Register Notices
10/24/2021
 
 
TXT Product Approval Summaries
10/24/2021
 
 
TXT Hold on Tryp Therapeutics Eating Disorder Study
10/22/2021
 
 
TXT PD-1 Inhibitor BLA Yanked After Keytruda Approval
10/22/2021
 
 
TXT FDA Denies Vaccine EUA Revocation Petition
10/21/2021
 
 
TXT Merck Recalls 1 Lot of Cubicin
10/21/2021
 
 
TXT FDA Denies Stryker Patient Transport Exemption
10/20/2021
 
 
TXT Cook Medical Recalls Transseptal Needle
10/20/2021
 
 
TXT Stealth Bio NDA Gets Refuse-to-File Letter
10/20/2021
 
 
TXT QS Problems at Magnolia Medical Technologies
10/20/2021
 
 
TXT Court OKs FDA Injunction Against Grandma’s Herbs
10/20/2021
 
 
TXT CGMP Violations at Sircle Laboratories
10/19/2021
 
 
TXT FDA Warns 2 Physician Researchers
10/19/2021
 
 
TXT ‘Complete Response’ on Stem Cell Transplant Therapy
10/18/2021
 
 
 
 
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