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FDA-RELATED NEWS
 
 
 
TXT FDA Issues EUA for Janssen Covid Vaccine
03/01/2021
 
 
TXT Biden Pivoting on Commissioner Frontrunners
02/25/2021
 
 
TXT Months for FDA to Warn About Tianeptine: Consumer Reports
02/25/2021
 
 
TXT OPDP Cites ‘Misleading’ Paragard Consumer Video
02/23/2021
 
 
TXT FDA ‘Ambiguous’ Digital Health Enforcement Discretion
02/25/2021
 
 
TXT Blackfynn Adds Hahn to Company Board
02/23/2021
 
 
TXT PDUFA Reauthorization Pre-market Talks
02/24/2021
 
 
TXT FDA Labeling Health Claim Enforcement Up Under Biden: Attorneys
02/25/2021
 
 
TXT FDA Allows Pfizer Vaccine Warmer Storage Temp
02/25/2021
 
 
TXT OCP Met or Exceeded 2020 Goals: Report
02/24/2021
 
 
TXT Latest Federal Register Notices
02/28/2021
 
 
TXT Product Approval Summaries
02/28/2021
 
 
TXT Since Our Last Issue ...
02/28/2021
 
 
TXT Medtronic Recalls Valiant Navion Thoracic Stent Graft
02/26/2021
 
 
TXT FDA Seeks More Data on Merck Covid Drug
02/26/2021
 
 
TXT 331 Covid Tests, Sample Collectors Authorized
02/25/2021
 
 
TXT Former FDA Chief of Staff on Biden Covid Team
02/25/2021
 
 
TXT Aquestive Therapeutics NDA Resubmission Plans
02/25/2021
 
 
TXT 3 Ways to Speed Drug Approvals
02/24/2021
 
 
TXT FDA Extends Nitrosamine Risk Assessment Timeframe
02/24/2021
 
 
TXT Medical Device EUAs Likely to End in 2021: Recall Report
02/24/2021
 
 
TXT FDA Denies Sun Pharma Taclantis CRL Appeal
02/24/2021
 
 
TXT Takeaways from FDA Monograph Reform Webinar
02/23/2021
 
 
TXT FDA Denies Synergy Pharmaceuticals’ Linzess Petition
02/23/2021
 
 
TXT Latest FDA Warning Letters
02/23/2021
 
 
TXT GSK Wants Changes to OTC Drug Naming Guidance
02/23/2021
 
 
TXT Pacific Stem Cells Selling Unapproved Products: FDA
02/23/2021
 
 
TXT Study Finds Lack of Minority Groups in Vaccine Trials
02/22/2021
 
 
TXT AstraZenenca Withdraws Imfinzi Bladder Cancer Use
02/22/2021
 
 
TXT Modifying Vaccines, Tests Due to Variants: Woodcock
02/22/2021
 
 
 
 
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