Understanding the US FDA Drug Review and Approval Process

Date	Jun 8, 2017
Time	12:00 PM EDT
Cost	$198.00
Online

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

REGISTER NOW

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.