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FDA-RELATED NEWS
 
 
 
TXT CDER New Drugs Director Jenkins to Retire
12/05/2016
 
 
TXT Cures Act Promises FDA $500 mil. More, Heads to Senate
12/01/2016
 
 
TXT Stem Cell Anecdotal Claims ‘Worrisome’: Califf
12/01/2016
 
 
TXT FDA ‘Addicted’ to Industry Money: POGO Reports
12/01/2016
 
 
TXT Trump Taps Rep. Price as HHS Nominee
11/29/2016
 
 
TXT Public Citizen, Others Hit FDA on Intellectual Bias Exclusions
11/28/2016
 
 
TXT Guide on Clinical Pharmacology Drug Labeling
12/02/2016
 
 
TXT Jury Awards $1 Billion on Hip Implant Case
12/02/2016
 
 
TXT FDA Steps to Improve Combination Product Review
12/02/2016
 
 
TXT FDA Sets New Import Data Requirements
11/30/2016
 
 
TXT FDA Updates REMS List
12/01/2016
 
 
TXT FDA Denies Vanda Petition to Delay Generic Fanapt
11/30/2016
 
 
TXT Support for MDUFA 4
11/29/2016
 
 
TXT FDA, Apple Met Many Times in Last 3 Years
11/29/2016
 
 
TXT Latest Federal Register Notices
12/04/2016
 
 
TXT Since Our Last Issue ...
12/04/2016
 
 
TXT Product Approval Summaries
12/04/2016
 
 
TXT Draft Guidance on Pharmacokinetic Analyses Format/Content
12/01/2016
 
 
TXT Restrictions Sought on Generic Naloxone Products
11/30/2016
 
 
TXT CDER Data Standards Quarterly Report Out
11/30/2016
 
 
TXT Pfizer Positive Trial Results with Herceptin Biosimilar
11/30/2016
 
 
TXT Latest FDA Warning Letters
11/29/2016
 
 
TXT CGMP Violations at China’s Dongying Tiandong
11/29/2016
 
 
TXT PADE Reporting Violations at STI Pharma
11/29/2016
 
 
TXT Industry Improves Drug Postmarketing Requirements Reporting
11/29/2016
 
 
TXT Untitled Letter to Dr. PRP America Over Unapproved Device
11/29/2016
 
 
TXT Safety Outcomes Committee MAPP Out
11/29/2016
 
 
TXT Key Provisions of ClinicalTrials.gov Final Rule
11/29/2016
 
 
TXT Guide on Mitigating Risks With Endoscope Irrigation
11/28/2016
 
 
 
 
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