FDA Webview Site FDA Review Site FDA Updater Site
header.gif
Username:
Password:
 

human drugs
animal drugs
biologics
eirs 483s
medical devices
marketing
email
search our site
  
FDA-RELATED NEWS
 
 
 
TXT Hill Letter Seeks GAO Morcellator Probe at FDA [644 Words]
07/21/2015
 
 
TXT Multiple Violations Found at 2 Bard Facilities [596 Words]
07/21/2015
 
 
TXT Need to Refine MDUFMA, Add New Components: Shuren [929 Words]
07/22/2015
 
 
TXT Appeals Court Finds Sandoz did not Violate Biosimilars Act [378 Words]
07/21/2015
 
 
TXT CDRH Using ‘Objective Performance Criterion’ for Easier Trials [330 Words]
07/24/2015
 
 
TXT Bill to Streamline Combination Product Approval [447 Words]
07/21/2015
 
 
TXT FDA Plans DTC Ad Study on Efficacy v. Marketing Claims [207 Words]
07/20/2015
 
 
TXT Product Approval Summaries [794 Words]
07/26/2015
 
 
TXT Since Our Last Issue ... [281 Words]
07/26/2015
 
 
TXT Latest Federal Register Notices [1070 Words]
07/26/2015
 
 
TXT Groups Seek Changes to HCT/P Adverse Event Reporting [560 Words]
07/24/2015
 
 
TXT Guidance on Analytical Procedures/Methods Validation [92 Words]
07/24/2015
 
 
TXT Expand Peds Device Data Extrapolation: AdvaMed [324 Words]
07/23/2015
 
 
TXT In Vivo BA/BE Studies Waiver Guidance Wins Praise [297 Words]
07/23/2015
 
 
TXT Troubled Wockhardt Passes FDA Inspection in India [193 Words]
07/23/2015
 
 
TXT 6 PhotoMedex Inspection Violations Detailed [298 Words]
07/23/2015
 
 
TXT Group Praises Shorter Toxicology Requirements [358 Words]
07/23/2015
 
 
TXT Investors Seek Drug Company Transparency [204 Words]
07/23/2015
 
 
TXT Request for Study Data Standard Information [389 Words]
07/22/2015
 
 
TXT Courts See ‘Materiality’ in False Claims Act Cases [395 Words]
07/22/2015
 
 
TXT ‘Significant Concerns’ with CMC Draft Guidance [259 Words]
07/22/2015
 
 
TXT FDA Schedules Meeting on Essure Implant [264 Words]
07/22/2015
 
 
TXT Biosimilars Case: Does ‘Shall’ Always Mean ‘Must’? [800 Words]
07/22/2015
 
 
TXT Companies Question Draft Promotional Guidance [312 Words]
07/21/2015
 
 
TXT Latest FDA Warning Letters [815 Words]
07/21/2015
 
 
TXT Amgen Seeks Clear Labels on Biosimilar Interchangeability [402 Words]
07/21/2015
 
 
TXT Teva Backs 3M Albuterol Sulfate MDI Petition [241 Words]
07/21/2015
 
 
TXT AdvaMed Concerns About Clinical Data Draft Guidance [340 Words]
07/21/2015
 
 
TXT Clinical Decision Software Info Sought [451 Words]
07/21/2015
 
 
TXT Ad Group Wants Only Benefit Info in Space Limited Social Media [438 Words]
07/20/2015
 
 
 
 
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
_