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FDA-RELATED NEWS
 
 
 
TXT FDA REVIEW NEWSROOM CLOSED FOR THE HOLIDAYS [34 Words]
12/18/2014
 
 
TXT David Kessler Wrong on 510(k) Law’s Intent, Lawyer Says [364 Words]
12/16/2014
 
 
TXT 2 Charged with Murder in NECC Compounding Rx Deaths [559 Words]
12/17/2014
 
 
TXT Aptiom Print Ad Overstates Efficacy: OPDP [372 Words]
12/18/2014
 
 
TXT Hamburg Touts FDA Steps on Compounded Drugs [376 Words]
12/17/2014
 
 
TXT QS Violations Found in Karl Storz Endovision [388 Words]
12/16/2014
 
 
TXT FDA Testing Drone Technology, But Not for Inspections [237 Words]
12/18/2014
 
 
TXT Maisel Lists CDRH Strategic Priorities [339 Words]
12/16/2014
 
 
TXT FDA Increasing Inspection Staff in China [392 Words]
12/18/2014
 
 
TXT Veloxis Sues FDA to Force Approval of Envarsus XR [216 Words]
12/17/2014
 
 
TXT DoJ Nixes Prosecution of Pair Who Used Unapproved Drugs in Practice [186 Words]
12/16/2014
 
 
TXT UDI Account Requests for Life-supporting Implants [218 Words]
12/19/2014
 
 
TXT PhRMA Concerned on REMS Training as Part of Continuing Education [349 Words]
12/19/2014
 
 
TXT FDA Asks Herbalife to Pull Misleading Video [187 Words]
12/19/2014
 
 
TXT Product Approval Summaries [618 Words]
12/18/2014
 
 
TXT Latest Federal Register Notices [1306 Words]
12/18/2014
 
 
TXT FDA Mulls Changes to Drug-induced Liver Injury Guidance [296 Words]
12/18/2014
 
 
TXT Industry Using ‘Political Clout’ to Block Biosimilars: Public Citizen [394 Words]
12/18/2014
 
 
TXT Since Our Last Issue ... [427 Words]
12/18/2014
 
 
TXT FDA Issues Form 483 After Inspection at Hovione Portugal Facility [144 Words]
12/18/2014
 
 
TXT GPhA Expresses ‘Changes Being Effected’ Rule Concerns [408 Words]
12/18/2014
 
 
TXT Apotex Seeks Approval of Neulasta Biosimilar Product [101 Words]
12/17/2014
 
 
TXT Court Nixes FDA Generic Celebrex Exclusivity Decision [444 Words]
12/17/2014
 
 
TXT Appeals Court Affirms Bayer Whistleblower Award [164 Words]
12/17/2014
 
 
TXT Electronic Format Guidances Out [2907 Words]
12/17/2014
 
 
TXT Distributors Seek Supply Chain ‘Enforcement Discretion’ [390 Words]
12/17/2014
 
 
TXT Latest FDA Warning Letters [398 Words]
12/16/2014
 
 
TXT 2 Innovations Can Change Drug Production: Consultants [449 Words]
12/16/2014
 
 
TXT Point-of-Care Communication Channel Growing: Consultants [281 Words]
12/16/2014
 
 
TXT FDA Proposes Rule on E-prescribing Information [195 Words]
12/16/2014
 
 
 
 
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