Understanding the US FDA Drug Review and Approval Process

  • Speaker:Dr. David Lim
  • Duration:70Min
  • Product Code:GRC-90413

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Certification: GRCTS Completion Certificate

Why you must attend:

  • The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs.
  • To introduce a new drug product into the U.S. market, some firms submit a new drug application (NDA) to the US FDA/CDER.
  • The firms are responsible for testing a drug and for submitting evidence that the drug is safe and effective.
  • In 2014 and 2015, the FDA/CDER has approved 41 and 45 novel drugs, respectively.
  • This webinar is intended to help you better understand FDA’s drug review and approval process. The FDA’s recent approvals of novel drugs will also be discussed.
  • The speaker will walk you through the regulatory requirements for FDA’s drug review and approvals.

Areas Covered in the Session:

  • Laws.
  • Regulations.
  • FDA Guidances.
  • Definitions.
  • Regulatory Requirements for New Drug Application (NDA) and Biologic License Application (BLA).
  • Drug Development.
  • FDA Drug Review and Approval.
  • Common Mistakes.
  • Critical Considerations.
  • Enforcement Actions.
  • Recent FDA Approvals.
  • PASS-IT Recommendations.

Who will benefit :

  • CEOs.
  • VPs.
  • Compliance Officers.
  • Attorneys.
  • Regulatory Affairs.
  • Clinical Affairs.
  • Quality Assurance.
  • R&D.
  • Consultants.
  • Contractors/Subcontractors.
  • Anyone Interested in the FDA Drug Review and Approval Processes.

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspection observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$259

CD-DVD: Shipped within 2 working days

$409

USB - Shipped within 2 working days

$429

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$3,249

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,759

Recording Access to 10 Members: 10 Participants can access the training Recording for 6 months from any location

$1,249

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