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FDA-RELATED NEWS
 
 
 
TXT Ban Pre-Term Birth Drug Makena: Public Citizen
10/08/2019
 
 
TXT 2 Final Coronary Guidances Out
10/09/2019
 
 
TXT Prices Increases Not Justified for 7 Drugs: ICER
10/08/2019
 
 
TXT Challenges of ‘N-of-one’ Medicine: Woodcock, Marks
10/10/2019
 
 
TXT FDA Hits Troubled Aurobindo with Form-483
10/08/2019
 
 
TXT JAMA Article Raises Doubt on Replicating Trials
10/11/2019
 
 
TXT UTC Laboratories Settles FCA Charges for $42.6 Million
10/10/2019
 
 
TXT Jury Awards $8 Billion in Risperdal Case
10/08/2019
 
 
TXT Death Misclassifications in MAUDE Database
10/09/2019
 
 
TXT In Vitro Diagnostic Submission Streamlined Guidance
10/09/2019
 
 
TXT FDA Denies Olmesartan Withdrawal Petition
10/09/2019
 
 
TXT California Law Combats ‘Pay-for-Delay’ Agreements
10/08/2019
 
 
TXT FDA Monitors Heparin Makers Due to Swine Fever
10/07/2019
 
 
TXT Product Approval Summaries
10/13/2019
 
 
TXT Latest Federal Register Notices
10/13/2019
 
 
TXT Since Our Last Issue ...
10/13/2019
 
 
TXT FDA Hits Cipla in India with 38-page Form-483
10/11/2019
 
 
TXT ICU Recalls Infusion Sets Over Leak Issue
10/10/2019
 
 
TXT 7 Observations on Aurobindo FDA-483
10/10/2019
 
 
TXT FDA Works on Improved Vaccine Candidate
10/10/2019
 
 
TXT New FDA-Track BsUFA Performance Dashboard Out
10/10/2019
 
 
TXT Comments on Inactive Ingredient Database Guidance
10/10/2019
 
 
TXT FDA Software Guidance Discussed
10/09/2019
 
 
TXT Clarus Wants FDA Testosterone-Ester Guidance
10/09/2019
 
 
TXT 6 FDA Software Exemption Guidances Analyzed
10/08/2019
 
 
TXT Multiple Violations at Herbal Healer Academy
10/08/2019
 
 
TXT FDA Funds 2 Natural History Studies
10/08/2019
 
 
TXT Class 1 Recall of Medtronic Guide Catheter
10/08/2019
 
 
TXT General, Specific Comments on ICH Clinical Studies Guidance
10/08/2019
 
 
TXT Latest FDA Warning Letters
10/08/2019
 
 
 
 
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