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FDA-RELATED NEWS
 
 
 
TXT FDA Approves First CGT Generic Drugs
08/08/2018
 
 
TXT Drug Recalls Dropped in 2nd Quarter
08/08/2018
 
 
TXT Drug Complex Innovative Designs Pilot Program
08/09/2018
 
 
TXT FDA to Study Ad Disclosures
08/09/2018
 
 
TXT Insys Therapeutics Agrees to $150 Million Fine with DoJ
08/08/2018
 
 
TXT Don’t Impose 30-Day SIR Deadline: AdvaMed
08/07/2018
 
 
TXT Cancer Groups Offer Oncology Trial Guidance
08/09/2018
 
 
TXT FDA Extends 1 GUDID Compliance Date
08/09/2018
 
 
TXT AstraZeneca Settles Texas Medicaid Suits for $110 Million
08/08/2018
 
 
TXT Testkitmart Distributing Unapproved HIV Tests: CBER
08/07/2018
 
 
TXT Dissolution Testing and Acceptance Criteria Guidance
08/08/2018
 
 
TXT Rupture of Membranes Tests Have Limits: FDA
08/08/2018
 
 
TXT 8 Observations in Celltrion FDA-483
08/07/2018
 
 
TXT CGMP Deviations at Les Produits Chimiques
08/07/2018
 
 
TXT Latest Federal Register Notices
08/12/2018
 
 
TXT Product Approval Summaries
08/12/2018
 
 
TXT Since Our Last Issue
08/12/2018
 
 
TXT Draft Guide on Modernizing Clinical Trial Designs
08/10/2018
 
 
TXT Spacelabs Healthcare Recalls Anesthesia Device
08/10/2018
 
 
TXT Vyaire Medical Recalls AirLife Resuscitation Device
08/10/2018
 
 
TXT FDAers Find Increases in Tropical Disease Drug Development
08/10/2018
 
 
TXT Elevair Emphysema Device ‘Not Approvable’: FDA
08/09/2018
 
 
TXT Guide on Drug Product Elemental Impurities
08/08/2018
 
 
TXT Qiagen Sciences Recalls Membrane Rupture Test
08/08/2018
 
 
TXT Latest FDA Warning Letter
08/07/2018
 
 
TXT ICH Elemental Impurities Guidance
08/07/2018
 
 
TXT Clarification Sought in Oncology Trial Inclusion Guidance
08/07/2018
 
 
TXT Guide on Opioid Use Disorder Trial Endpoints
08/06/2018
 
 
 
 
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