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Pharmaceutical Approvals Monthly
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Pharmaceutical Approvals Monthly


In-depth coverage of U.S. drug approvals, including FDA approval actions by classification.


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Pharmaceutical Approvals Monthly is a unique publication that delivers comprehensive, actionable intelligence on the entire scope of the drug development and approval process in one single, easy-to-use resource, allowing executives to develop powerful strategies that expedite their product and ensure a smooth ride through the approval process.

Pharmaceutical Approvals Monthly delivers expert, behind-the-scenes coverage and analysis of every step of the drug approval process, helping executives know which competing products are in the pipeline, learn from other company’s mistakes, prepare for the difficult new REMS requirements and more.

Every month, Pharmaceutical Approvals Monthly delivers comprehensive coverage of:

  • Drug review profiles from beginning to end of the entire approval process
  • Drug approval strategies developed by your competitors
  • Pending FDA applications
  • Key FDA approval decisions, broken down by original, supplemental and ANDA classifications
  • Estimated user fee goals
  • Advisory committee recommendations
  • REMS requirements and the criteria that trigger them
  • Pipeline analysis
  • “Complete response” actions

 

Your subscription to Pharmaceutical Approvals Monthly will include:

  • Online access: Searchable access to a rolling 90 or 365 days of content
  • Online access to comprehensive drug approval tables by month; advisory committee meeting dates and recommendations; R&D news briefs
  • Topical RSS Feeds
  • Email updates: Email newsletter plus breaking news delivered to your inbox
  • Archives: Available access to the information you need from our complete archive
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Includes: Email newsletter with latest headlines, breaking news alerts, and access to Pharmaceutical Approvals Monthly — in-depth coverage of U.S. drug approvals, including FDA approval actions by classification.

Multiple users/site features: Contact Deanna Flanick at +1-908-547-2141 or D.Flanick@Elsevier.com.