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FDA-RELATED NEWS
 
 
 
TXT Prior Decisions Should Guide New Drug Reviews: Researchers
09/21/2021
 
 
TXT CDC Backs Most of FDA EUA for Covid Booster
09/23/2021
 
 
TXT AdvaMed Comments on FDA Device Remanufacturing Guidance
09/23/2021
 
 
TXT MITA Concerns With FDA Remanufacturing Guidance
09/22/2021
 
 
TXT Reverse CA Decision Punishing Scientific Speech: WLF
09/23/2021
 
 
TXT FDA Goals for BsUFA 3 Released
09/22/2021
 
 
TXT FDA Revises Authorizations of Some Covid Tests
09/23/2021
 
 
TXT Court Nixes FDA Compounding MOU with States
09/22/2021
 
 
TXT Workshop on Orthopedic Device-Related Infections
09/22/2021
 
 
TXT Attorneys See Good Things in PDUFA 7 Goals
09/21/2021
 
 
TXT Genesis Medical Sellng Unapproved Adipose Cellular Products: FDA
09/23/2021
 
 
TXT J&J Touts Vaccine Booster Data
09/21/2021
 
 
TXT Since Our Last Issue ...
09/26/2021
 
 
TXT Latest Federal Register Notices
09/26/2021
 
 
TXT Product Approval Summaries
09/26/2021
 
 
TXT FDA Extends Review of Pfizer Growth Hormone
09/24/2021
 
 
TXT FDA Generic Drugs Office Modifies Scientific Priorities
09/24/2021
 
 
TXT Cordis Recalls Angiographic Catheter
09/23/2021
 
 
TXT Suspend Vitamin B6 Sales: Emery Pharma Petition
09/23/2021
 
 
TXT 10 Observations in Greenpark FDA-483
09/23/2021
 
 
TXT CGMP, Other Violations at Furley Bioextracts
09/22/2021
 
 
TXT 4 FDA/ECRI Material Safety Summaries Out
09/22/2021
 
 
TXT ICH Meeting on Continuous Manufacturing, Other Topics
09/21/2021
 
 
TXT Panexcell, Synchron Studies Are ‘Unacceptable’: FDA
09/21/2021
 
 
TXT Paige Prostate AI Software Marketing Authorization
09/21/2021
 
 
TXT FDA Defers Action on Humira Biosimilar
09/21/2021
 
 
TXT ‘First’ Lucentis Biosimilar Approved by FDA
09/20/2021
 
 
TXT Guide on Controlled Correspondence Related to Quality
09/20/2021
 
 
TXT Medtronic Unit Recalls Brain Aneurysm Stents
09/20/2021
 
 
TXT FDA Complete Response on Verrica NDA
09/20/2021
 
 
 
 
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