Description:-

• 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