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FDA-RELATED NEWS
 
 
 
TXT 13% Boost in FDA Budget Proposed by Trump
02/12/2018
 
 
TXT White House Report Backs FDA Reforms to Help Curb Costs
02/09/2018
 
 
TXT Gottlieb Outlines New Efforts on Biosimilars, OTC Drugs and Opioids
02/07/2018
 
 
TXT Stakeholders Praise Intended Use Rule Delay
02/07/2018
 
 
TXT WLF Brief: Brand Drug Makers Not Liable for Generic Harm
02/09/2018
 
 
TXT High Court Asked to Consider Gilead Case
02/08/2018
 
 
TXT FDA Rejects Sandoz Proposed Generic Advair
02/08/2018
 
 
TXT 8 Observations in Zimmer Biomet FDA-483
02/07/2018
 
 
TXT Court Upholds Device Exempt, Implied Preemption
02/08/2018
 
 
TXT Simulations Cut Generic Drug Development: FDA
02/06/2018
 
 
TXT Latest Federal Register Notices
02/11/2018
 
 
TXT Product Approval Summaries
02/11/2018
 
 
TXT Since Our Last Issue ...
02/11/2018
 
 
TXT CDER External Stakeholder Meeting Request System
02/09/2018
 
 
TXT Philips Electronics Recalls HeartStart Defibrillator
02/09/2018
 
 
TXT FDA Issues Product-Specific Generic Drug Guidances
02/08/2018
 
 
TXT United Therapeutics Submits 5th Tyvaso Petition
02/08/2018
 
 
TXT FDA Issues GAIN Report
02/07/2018
 
 
TXT Partial Summary Judgment OKd in Medtronic Pump Case
02/07/2018
 
 
TXT Pentax Recalls Duodenoscopes to Replace Parts
02/07/2018
 
 
TXT FDA Posts Impurity Data Considerations
02/07/2018
 
 
TXT Latest FDA Warning Letters
02/06/2018
 
 
TXT CGMP Violations at Korea’s Celltrion
02/06/2018
 
 
TXT Polaroisin International CGMP Violations
02/06/2018
 
 
TXT FDA Gives Octo $300 Million Approval Process Contract
02/06/2018
 
 
TXT Revise Clinical Decision Support Guidance: Coalition
02/06/2018
 
 
TXT Guidance Helps Generics Industry Submit Better Apps
02/06/2018
 
 
TXT Group Seeks Removal of ‘Conflicted’ Panel Member
02/05/2018
 
 
TXT Safety Alert on Therakos Cellex Photopheresis System
02/05/2018
 
 
 
 
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