Understanding the US FDA Drug Review and Approval Process

MessageThis Webinar is over
Date Jun 8, 2017
Time 12:00 PM EDT
Cost $198.00
Product Format: Live Audio Conference
Speaker: David Lim 
Conference Date: Jun 08, 2017
Time: 01 : 00 pm EST
Duration: 60 minutes
Price: $198.00
  • The FDA's Center for Drug Evaluation and Research (CDER) is in charge of reviewing and endorsement of both prescription and nonprescription or over-the-counter (OTC) medicines.
  • In order to present a new drug product into the U.S. market, companies must present a new application of drugs (NDA) to the US FDA/CDER.
  • The firms are in charge of testing a drug and must present the proof showing that the drug is safe and efficient.
  • In 2015 and 2016, the FDA/CDER has confirmed 45 and 22 novel drugs, separately.
  • This online course is expected to help you enhance your comprehension of FDA's drugevaluation and endorsement procedure. It is additionally expected to present FDA's current endorsements of novel drugs.
  • The speaker will run through the FDA's drug evaluation and endorsement procedure.
Area covered in the session :
  • Laws and Regulations
  • Descriptions
  • Regulatory Prerequisitesfor New Drug Application (NDA)
  • Regulatory Prerequisites for Biologics License Application (BLA)
  • Drug Development Procedure
  • FDA Drug Review/Endorsement Procedure – Expected or Unexpected
  • Significant Considerations
  • Common PreventableErrors
  • Recent FDA Endorsements of Novel Drugs: First in Class, Uncommon Diseases, Fast Track, Breakthrough, Priority Review and Fast-trackedEndorsements
  • PASS-IT Recommendations
Who will benefit :
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Anyone Interested in the FDA Drug Review and Approval Processes
  • CEOs


Call us: +1-800-935-3714 or
Mail us: cs@onlineaudiotraining.com

Not able to attend the live audio session? We will provide you with a replay of the session, or you can request a DVD recording.


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