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FDA-RELATED NEWS
 
 
 
TXT Clinical Trial Meta-Analysis Guidance Out
11/06/2018
 
 
TXT FDA ‘Transitional Biologics’ Position ‘Ripe for Litigation’: Attorneys
11/07/2018
 
 
TXT FDA Modernizing Inspections with New Protocols
11/09/2018
 
 
TXT Senators Ask Trump to Support ‘Pay-for-delay’ Bill
11/09/2018
 
 
TXT Use of Voluntary Consensus Standards Guidance Explained
11/06/2018
 
 
TXT FDA Illegally Regulates Some Devices as Drugs: Attorney
11/08/2018
 
 
TXT Cardiac Testing Still Needed for Diabetes Drugs: LaMattina
11/08/2018
 
 
TXT New Monteris Medical NeuroBlate Probe Coming: FDA
11/08/2018
 
 
TXT Suggestions to Change Cancer Placebo Guidance
11/07/2018
 
 
TXT FDA Releases Akorn FDA-483 with 11 Observations
11/06/2018
 
 
TXT Product Approval Summaries
11/11/2018
 
 
TXT Since Our Last Issue ...
11/11/2018
 
 
TXT Latest Federal Register Notices
11/11/2018
 
 
TXT Record Generic Approvals Last Month
11/09/2018
 
 
TXT FDA Approves New OTC Primatene Mist
11/08/2018
 
 
TXT FDA Expanded Access Web Page Being Improved
11/08/2018
 
 
TXT FDA Posts MyStudies App Code
11/07/2018
 
 
TXT Some Roche Handheld Medical Devices at Risk: Report
11/07/2018
 
 
TXT 7 Observations in MedisourceRx FDA-483
11/07/2018
 
 
TXT ‘Serious Deficiencies’ at Atlantic Pharmacy and Compounding
11/06/2018
 
 
TXT Latest FDA Warning Letter
11/06/2018
 
 
TXT Generic Drug Industry’s Trade Agreement Concerns
11/06/2018
 
 
TXT Facilitating Surrogate Endpoints in Drug Development
11/06/2018
 
 
TXT Guide on Developing Hypertension Combo Drugs
11/06/2018
 
 
TXT Sandoz Scraps Rituxan Biosimilar Submission
11/05/2018
 
 
TXT FDA Hits Lupin with 5-item Form 483
11/05/2018
 
 
 
 
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