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FDA-RELATED NEWS
 
 
 
TXT Biosimilar Review ‘Straining Resources’: Woodcock [243 Words]
10/14/2014
 
 
TXT CDER Revamp Includes Office of Pharmaceutical Quality [854 Words]
10/16/2014
 
 
TXT Court Says Branded Drug Design Defects Preempted [219 Words]
10/16/2014
 
 
TXT FDA Says Generic BE Not Impacted by Software Concerns [193 Words]
10/16/2014
 
 
TXT FDA to Survey on Generic Drug Appearance Changes [287 Words]
10/14/2014
 
 
TXT FDA Guidance on Device Recalls vs. Enhancements [296 Words]
10/14/2014
 
 
TXT Court Orders Destruction of Unapproved Ascend Labs Drugs [192 Words]
10/14/2014
 
 
TXT PhRMA, BIO Attack Exclusivity Guidance for Biological Products [332 Words]
10/13/2014
 
 
TXT QS Violations Seen in Alpha Medical Inspection [338 Words]
10/14/2014
 
 
TXT Chinese Crude Heparin Firm Blocked FDA Inspection [451 Words]
10/14/2014
 
 
TXT Since Our Last Issue ... [1409 Words]
10/19/2014
 
 
TXT Latest Federal Register Notices [973 Words]
10/19/2014
 
 
TXT Product Approval Summaries [1676 Words]
10/19/2014
 
 
TXT FDA Approves ‘Abuse-deterrent’ Claim on Pfizer’s Enbeda [311 Words]
10/17/2014
 
 
TXT Will FDA Raise Cybersecurity Goals in Device Submissions? [242 Words]
10/17/2014
 
 
TXT Spectrum Wants Fusilev Approval Date, Exclusivity Extended [333 Words]
10/16/2014
 
 
TXT FDA Panel Votes to Retain Chantix Boxed Warning [288 Words]
10/16/2014
 
 
TXT High Court Mixed on Changing Federal Circuit’s Role in Patent Appeals [252 Words]
10/16/2014
 
 
TXT County Health System Wants Clozapine REMS Changed [350 Words]
10/16/2014
 
 
TXT ADR Network Wants Levaquin Psychiatric Labeling Info [368 Words]
10/15/2014
 
 
TXT NCTR Studying Pediatric Brain Function [385 Words]
10/15/2014
 
 
TXT Dietary Supplement Firms Don’t Know GMP: Consultant [306 Words]
10/15/2014
 
 
TXT 8 New, Updated REMS [189 Words]
10/15/2014
 
 
TXT ISPE Drug Shortage Prevention Plan Out [277 Words]
10/15/2014
 
 
TXT HealthCore in Five-year Sentinel Contract [322 Words]
10/14/2014
 
 
TXT Whistleblowers Sue AZ in Texas Over Seroquel [268 Words]
10/14/2014
 
 
TXT Court Says Some Medtronic Claims Not Preempted [396 Words]
10/14/2014
 
 
TXT Latest FDA Warning Letters [835 Words]
10/14/2014
 
 
TXT Pharmacist Group Wants Viagra in Behind-the-counter Status [74 Words]
10/13/2014
 
 
 
 
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