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FDA-RELATED NEWS
 
 
 
TXT FDA Loses Against Hospira in Precedex Carve-out Decision [216 Words]
08/20/2014
 
 
TXT FDA Enhancing Trial Data Collection, Availability [453 Words]
08/20/2014
 
 
TXT Concerns About FDA Regulating Through Guidance [540 Words]
08/21/2014
 
 
TXT Law Firm Urges Industry to Reject 510(k) Benefit-Risk Guidance [688 Words]
08/18/2014
 
 
TXT FDA Speeding PMA Approvals: Analysis [377 Words]
08/20/2014
 
 
TXT PhRMA Wants False Claims Case Thrown Out [334 Words]
08/19/2014
 
 
TXT FDA Targeting Informed Consent Revisions: Consultants [219 Words]
08/22/2014
 
 
TXT More Boxed Warning Research Needed: Blog [488 Words]
08/21/2014
 
 
TXT 8th Circuit Affirms Stryker, I-Flow Case Dismissal [354 Words]
08/20/2014
 
 
TXT Risk Minimization, Omission Most Common Drug Ad Issue [341 Words]
08/21/2014
 
 
TXT FDA Proposing ‘Master Protocol’ for Breast Cancer Trials [437 Words]
08/20/2014
 
 
TXT QS Violations Found in Nidek Inspection [307 Words]
08/19/2014
 
 
TXT Alabama Court Reaffirms Brand Liability in Generic Drug Harm Suits [217 Words]
08/18/2014
 
 
TXT Since Our Last Issue ... [1568 Words]
08/24/2014
 
 
TXT Latest Federal Register Notices [1330 Words]
08/24/2014
 
 
TXT Product Approval Summaries [1538 Words]
08/24/2014
 
 
TXT Senate HELP Committee Draft of Sunscreen Bill [171 Words]
08/22/2014
 
 
TXT DEA Rescheduling Hydrocodone Combination Products [277 Words]
08/21/2014
 
 
TXT Reject Teva Petition on Rescue Inhaler Counters: Mylan [264 Words]
08/21/2014
 
 
TXT FDA Extends UDI Compliance Date for Eye Lens Makers [162 Words]
08/21/2014
 
 
TXT Marck Biosciences Changes Its Name [253 Words]
08/20/2014
 
 
TXT CDRH Posts UDI Frequently-asked Questions Guidance [101 Words]
08/20/2014
 
 
TXT Feds Drop Probe on AstraZeneca PLATO Trial [302 Words]
08/19/2014
 
 
TXT FDA Mulls Public Process for ANDA 180-day Exclusivity Decisions [374 Words]
08/19/2014
 
 
TXT Docs Want Distinguishable Biologic Names [391 Words]
08/19/2014
 
 
TXT FDA Approves Labeling Changes for 73 Products [697 Words]
08/19/2014
 
 
TXT Latest FDA Warning Letters [795 Words]
08/19/2014
 
 
TXT FDA Making Open Access to MAUDE Data Available [384 Words]
08/19/2014
 
 
TXT Boxed Warnings Becoming More Prevalent on Drugs: Researchers [191 Words]
08/18/2014
 
 
TXT CDER Drug Safety Board Reviews Anticoagulants [252 Words]
08/18/2014
 
 
 
 
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