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FDA-RELATED NEWS
 
 
 
TXT Inspections Top Priority After Pandemic: Woodcock
04/14/2021
 
 
TXT Woodcock Announces Cavazzoni as CDER Head
04/12/2021
 
 
TXT Covid Remote Interactive Drug Facility Evaluation Guidance
04/14/2021
 
 
TXT Covid Led to Multiple Work Delays: CDRH
04/15/2021
 
 
TXT FDA,CDC Urge Pause in J&J Vaccination
04/13/2021
 
 
TXT FDA Remote Inspections Could Continue After Pandemic: Attorneys
04/15/2021
 
 
TXT Cut GDUFA Fees to Promote Competition: Analysis
04/15/2021
 
 
TXT Add All Lorcaserin Drugs to List of Drugs Not to Compound: Public Citizen
04/13/2021
 
 
TXT 5th Circuit Backs FTC in Impax ‘Reverse Payment’ Case
04/13/2021
 
 
TXT Senate Approves FDA ‘Active Moiety’ Definition
04/13/2021
 
 
TXT Medtronic Thoracic Stent Class 1 Recall
04/12/2021
 
 
TXT Since Our Last Issue ...
04/18/2021
 
 
TXT Latest Federal Register Notices
04/18/2021
 
 
TXT Product Approval Summaries
04/18/2021
 
 
TXT BD Recall of Alaris Pump Due to Keypad
04/16/2021
 
 
TXT Panbela Therapeutics Clinical Hold Lifted
04/15/2021
 
 
TXT Qorvo EUA for Covid Antigen Test
04/15/2021
 
 
TXT FDA Taps Intertek for Device Conformity Assessments
04/15/2021
 
 
TXT Merck Scraps Covid Therapy on Data Request
04/15/2021
 
 
TXT Genesis Herb Operators to Plead Guilty to FDA Charges
04/14/2021
 
 
TXT ALS Group Seeks Faster OK for Amylyx Experimental Drug
04/14/2021
 
 
TXT New CDRH Learn Modules Posted
04/14/2021
 
 
TXT CBER Planning 16 Guidances in CY 2021
04/14/2021
 
 
TXT FDA Agrees to DefenCath Study from CRL
04/14/2021
 
 
TXT CGMP Deviations at Proquimes SA Productos Quimicos Especializados
04/13/2021
 
 
TXT Braintree Wants Restrictions on Tablet Colonoscopy Prep
04/13/2021
 
 
 
 
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