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FDA-RELATED NEWS
 
 
 
TXT PhRMA Defends its Free Speech Position [400 Words]
09/10/2014
 
 
TXT Focusing Drug Trial Protocols is Working: Tufts [497 Words]
09/09/2014
 
 
TXT Another Off-label Nightmare for FDA: Blog [499 Words]
09/10/2014
 
 
TXT Curtail Ex-Advisory Committee Member ‘Hired Guns’: Public Citizen [277 Words]
09/10/2014
 
 
TXT Draft Informed Consent Guidance Praised, Questioned [374 Words]
09/11/2014
 
 
TXT Comparative Ad Claims Can Mislead Consumers: Studies [359 Words]
09/11/2014
 
 
TXT Courts Should Not Subvert Congress, FDA: WLF Paper [348 Words]
09/11/2014
 
 
TXT CDRH Director Shuren Dismisses Hill Calls for LDT Rulemaking [888 Words]
09/09/2014
 
 
TXT Report Questions Benefit of Being First Drug to Market [220 Words]
09/12/2014
 
 
TXT CDER Denies Amarin Appeal on Special Protocol for Vascepa [171 Words]
09/12/2014
 
 
TXT Court Rejects FDA Attempt to Block Orphan Exclusivity [342 Words]
09/12/2014
 
 
TXT Biosimilars ‘Orange Book’ is Purple [198 Words]
09/09/2014
 
 
TXT Product Approval Summaries [319 Words]
09/21/2014
 
 
TXT Product Approval Summaries [359 Words]
09/14/2014
 
 
TXT Since Our Last Issue ... [1506 Words]
09/14/2014
 
 
TXT Latest Federal Register Notices [1354 Words]
09/14/2014
 
 
TXT Market Forces Behind Drug Shortages: Policy Brief [311 Words]
09/11/2014
 
 
TXT Pediatric Group Wants Exclusivity Tied to Written Requests Only [274 Words]
09/11/2014
 
 
TXT Data and System Security Issues in GMP Warning Letters [236 Words]
09/11/2014
 
 
TXT Don’t Review Alkermes NDA: Otsuka [259 Words]
09/11/2014
 
 
TXT FDA Inspects Recall-prone Sun Pharma Plant in India [184 Words]
09/11/2014
 
 
TXT FDA Wants Statistical Analyses on Sex Differences in Device Studies [587 Words]
09/10/2014
 
 
TXT Group Says It’s Uncovered Unreported Drug Adverse Events [344 Words]
09/10/2014
 
 
TXT Digital Coalition Sees Unclear Twitter Guidance Impact [495 Words]
09/10/2014
 
 
TXT Court Rejects 2nd FDA Diphoterine Classification [353 Words]
09/10/2014
 
 
TXT U.S. Files Charges Against Reliance Medical, Others [206 Words]
09/09/2014
 
 
TXT CDER Recruits DoJ Lawyer to Head Compliance Office [285 Words]
09/09/2014
 
 
TXT Latest FDA Warning Letters [144 Words]
09/09/2014
 
 
TXT FTC Says Companies Blocked Generic AndroGel [436 Words]
09/09/2014
 
 
TXT Oral Arguments Set in Biosimilars Declaratory Judgment Appeal [245 Words]
09/08/2014
 
 
TXT FDA Device Inspections Up 25% Over Past Five Years [239 Words]
09/08/2014
 
 
 
 
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