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FDA-RELATED NEWS
 
 
 
TXT Woodcock Backs Patient Input, Expanded Sentinel in Next PDUFA
08/16/2016
 
 
TXT CGMP Issues Found in China’s Zhejiang Medical
08/16/2016
 
 
TXT CGMP Violations in Noven Inspection
08/16/2016
 
 
TXT Compliance Remediation Projects Needed: Consultants
08/16/2016
 
 
TXT FDA Worried About Resources Required to Review Citizen Petitions
08/19/2016
 
 
TXT Kentucky Sues J&J Over ‘Inadequate’ Mesh Warnings
08/17/2016
 
 
TXT Most People Want to Join Precision Medicine Study: NIH
08/18/2016
 
 
TXT Drug User Fees Total $7.67 Billion in 24 Years
08/17/2016
 
 
TXT Sequencing Regulatory Pathway ‘Helpful’: Comment
08/17/2016
 
 
TXT AdvaMed Backs Coverage of all IDE Trials
08/17/2016
 
 
TXT Court Rejects Forest RICO Suit
08/17/2016
 
 
TXT Combination Product Review Process ‘Unsettling’: Attorney
08/17/2016
 
 
TXT Product Approval Summaries
08/21/2016
 
 
TXT Since Our Last Issue ...
08/21/2016
 
 
TXT CDRH Outlines Requests for Alternative UDI Approaches
08/19/2016
 
 
TXT Device Panel Supports OTC Tests for STDs
08/19/2016
 
 
TXT AABB Suggests Biologics Forms Modifications
08/18/2016
 
 
TXT Medtronic Cautions on EnVeo Catheter Risks
08/18/2016
 
 
TXT Environmentalists Want Sunscreen Evaluation
08/18/2016
 
 
TXT Court Rules Remicade Patent Invalid
08/17/2016
 
 
TXT Don't Use Custom Ultrsonics Reprocessors for Scopes: FDA
08/17/2016
 
 
TXT Nucleic Acid Test Guidance
08/17/2016
 
 
TXT CDER Draft Guide on Pharmaceutical Co-Crystals
08/16/2016
 
 
TXT Dissemination of Patient-Specific Information Guidance
08/16/2016
 
 
TXT Latest FDA Warning Letters
08/16/2016
 
 
TXT Supreme Court Asked to Look at Bioequivalence Safe Harbor
08/16/2016
 
 
TXT Latest Federal Register Notices
08/14/2016
 
 
 
 
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