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FDA-RELATED NEWS
 
 
 
TXT FDA Gets ‘Extraordinary’ Response to Human Factors Guidance [1744 Words]
05/15/2013
 
 
TXT Appeals Court Grants Temporary Stay on Plan B [220 Words]
05/14/2013
 
 
TXT House Committee Passes Legislation on Drug Supply Chain [527 Words]
05/15/2013
 
 
TXT House Investigators Probe FDA Deputy’s Sudden Departure [297 Words]
05/13/2013
 
 
TXT FDA Not Changing Advertising Enforcement Post-Caronia [545 Words]
05/16/2013
 
 
TXT 510(k) Program is ‘Sound and Well Worth Reforming’: Attorney [307 Words]
05/14/2013
 
 
TXT Ranbaxy Pays $500 Million Over Adulterated Drugs [474 Words]
05/13/2013
 
 
TXT FDA Finds ‘Significant Concerns’ with Hospira Infusion Pumps [371 Words]
05/16/2013
 
 
TXT 41 State Attorneys General Want Neonatal Warning on Opioids [178 Words]
05/14/2013
 
 
TXT C.R. Bard Agrees to Pay $48 Million Over Illegal Kickbacks [168 Words]
05/14/2013
 
 
TXT Senators Introduce Compounding Bill [248 Words]
05/15/2013
 
 
TXT FDA-483 Analysis Finds Increasing QSR Citations [191 Words]
05/13/2013
 
 
TXT House Dems Introduce Clinical Trials Reporting Bill [144 Words]
05/17/2013
 
 
TXT FDA Moves Ahead on DTC Study on Composite Endpoint Scores [417 Words]
05/13/2013
 
 
TXT Latest Federal Register Notices [1189 Words]
05/19/2013
 
 
TXT Since Our Last Issue ... [495 Words]
05/19/2013
 
 
TXT Product Approval Summaries [915 Words]
05/19/2013
 
 
TXT Companies Seek Changes to Post-approval Modifications Guidance [498 Words]
05/17/2013
 
 
TXT CDRH Releases 2 Draft Appeals Process Guidances [157 Words]
05/16/2013
 
 
TXT Labeling Changes Approved for 48 Drug Products in April [352 Words]
05/16/2013
 
 
TXT Concerns Raised on Product Design Draft Guidance [267 Words]
05/16/2013
 
 
TXT 2 Drug Safety Signals Identified in First Quarter [76 Words]
05/16/2013
 
 
TXT AdvaMed Has Concerns About Infusion Pump Guidance [205 Words]
05/16/2013
 
 
TXT Improvements Sought in Draft Diagnostic Device Guidance [285 Words]
05/16/2013
 
 
TXT 2 New and 8 Updated Medication Guides Out [68 Words]
05/16/2013
 
 
TXT Public Citizen Criticizes HELP Committee Compounding Bill [226 Words]
05/16/2013
 
 
TXT Latest FDA Warning Letters [962 Words]
05/15/2013
 
 
TXT Quality System Violations at Italy’s Interlab [263 Words]
05/15/2013
 
 
TXT Inspection Finds QS Problems at Electromedical Products [213 Words]
05/15/2013
 
 
TXT FDA Accepts Invacare Consent Decree Audit [512 Words]
05/14/2013
 
 
TXT Virology Studies Assay Guidance Sought [225 Words]
05/14/2013
 
 
TXT Safety Study Guidance Out [140 Words]
05/14/2013
 
 
TXT BIO Seeks Modifications to Periodic Safety Reports Guidance [361 Words]
05/13/2013
 
 
 
 
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;
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You can rely on FDA Review to provide only what's important - in the most convenient and time-saving