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FDA-RELATED NEWS
 
 
 
TXT Ban-LASIK Petitioner Charges FDA with ‘Data Conflation’ [341 Words]
07/23/2014
 
 
TXT Using REMS as a Generic Drug Delaying Strategy [291 Words]
07/23/2014
 
 
TXT FDA Mulls Drug Name Reservation Program [431 Words]
07/25/2014
 
 
TXT Final Guidance on 510(k) Substantial Equivalence Considerations [306 Words]
07/25/2014
 
 
TXT Dietary Supplement Maker Signs Consent Decree [121 Words]
07/25/2014
 
 
TXT PMAs Being Approved Twice as Fast This Year [132 Words]
07/25/2014
 
 
TXT FDA Should Deny Petitions on Biosimilar Naming: Alliance [182 Words]
07/25/2014
 
 
TXT Latest Federal Register Notices [848 Words]
07/24/2014
 
 
TXT FDA Grants, Denies Parts of AndroGel Petitions [412 Words]
07/24/2014
 
 
TXT FDA Revises Draft Guide on Drug/Biologic eSubmissions [107 Words]
07/24/2014
 
 
TXT BMJ Challenges Boehringer-Ingelheim Dabigatran Data [468 Words]
07/24/2014
 
 
TXT Animal Antibiotic FDA Hearing Case Reversed [383 Words]
07/24/2014
 
 
TXT Technical/Editorial Comments on Heparin Guidance [175 Words]
07/24/2014
 
 
TXT Sandoz Files First Biosimilar for Filgrastim [132 Words]
07/24/2014
 
 
TXT Another Indian Firm Cited for GMPs, Data Integrity [342 Words]
07/24/2014
 
 
TXT Since Our Last Issue ... [337 Words]
07/24/2014
 
 
TXT Product Approval Summaries [546 Words]
07/24/2014
 
 
TXT Merck Wants FDA to Implement New 5-year Exclusivity Policy [311 Words]
07/23/2014
 
 
TXT New Informed Consent Guidance [244 Words]
07/23/2014
 
 
TXT OIG Finds One-Third of Drug Makers Not Reporting Prices [120 Words]
07/23/2014
 
 
TXT Court Dismisses Solodyn Suit [277 Words]
07/23/2014
 
 
TXT Law Professors Debate Off-Label Drug Promotion [311 Words]
07/23/2014
 
 
TXT American Intl. Biotech Settles False Claims Suit [259 Words]
07/23/2014
 
 
TXT QS Violations Found in Carefusion Inspection [397 Words]
07/22/2014
 
 
TXT 2 Internatl. Single Audit Documents for Devices Out [266 Words]
07/22/2014
 
 
TXT Groups Oppose Antibacterial Drug Trial Changes [470 Words]
07/22/2014
 
 
TXT Latest FDA Warning Letters [784 Words]
07/22/2014
 
 
TXT FDA Plans Biomarker Public Meeting and Future Guidance [146 Words]
07/21/2014
 
 
TXT CDER Says eDMF Submissions Get Processed Faster [106 Words]
07/21/2014
 
 
TXT CDER Names Key Leaders in ‘Super’ Generic Drug Office [930 Words]
07/21/2014
 
 
 
 
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