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
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