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FDA-RELATED NEWS
 
 
 
TXT Senators Seek Trump Admin. Actions to Cut Drug Costs
05/15/2017
 
 
TXT Gottlieb Talks to Staff About Scientific Advances, Priorities
05/19/2017
 
 
TXT Eyes on Gottlieb as He Heads for First Hill Testimony
05/19/2017
 
 
TXT House Health Subcommittee Advances User Fee Bill
05/18/2017
 
 
TXT AdvaMed Praises Bill Streamlining Some Device Approvals
05/18/2017
 
 
TXT Gottlieb Will Have to Decide Future of Efficacy Standard: Schultz
05/17/2017
 
 
TXT CDER Sees No Negatives with Expanded Access Decisions
05/15/2017
 
 
TXT FDA Asked to Stay Roxybond NDA Approval
05/18/2017
 
 
TXT Researchers Find ‘Moderate’ Trust in FDA
05/17/2017
 
 
TXT Price Wants FDA Reviews ‘100% User Fee Supported’
05/17/2017
 
 
TXT Supreme Court Rejects Lawyers’ Risperdal Appeal
05/18/2017
 
 
TXT Don’t Exempt Drug Assays from 510(k): Sharfstein
05/17/2017
 
 
TXT Latest Federal Register Notices
05/21/2017
 
 
TXT Since Our Last Issue ...
05/21/2017
 
 
TXT Product Approval Summaries
05/21/2017
 
 
TXT FDA Releases Sekisui Medical FDA-483
05/19/2017
 
 
TXT Court Dismisses Eliquis Case
05/18/2017
 
 
TXT Oncology ‘Excellence’ Center Handling Reviews: Pazdur
05/18/2017
 
 
TXT Administration Considers Capping NIH Indirect Costs
05/18/2017
 
 
TXT Lawyer Urges Whistleblower Case Discovery Stay
05/18/2017
 
 
TXT Califf Accepts Dual Role at Duke Health/Verily
05/17/2017
 
 
TXT AZ Wants Restrictions on Applications Citing Faslodex
05/17/2017
 
 
TXT Some Magellan Lead Tests May be Inaccurate: FDA
05/17/2017
 
 
TXT CDER Holding Preventable Harm Symposium
05/17/2017
 
 
TXT QS and MDR Violations Found at Vidco
05/16/2017
 
 
TXT PADE Violations Found at Vertical Pharmaceuticals
05/16/2017
 
 
TXT Latest FDA Warning Letters
05/16/2017
 
 
TXT Company Speaker Programs FCA Focus
05/16/2017
 
 
TXT Senators Concerned About ‘Cures Bill’ Budget Cuts
05/16/2017
 
 
 
 
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