505(B)(2) APPLICATIONs; Standards for Approval


Friday, February 15, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 60 Minutes      

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By attending this webinar you will learn the basis for FDA acceptance and rejection for 505 (b) (2) Application.

Lamont M. Fulton   Product Id : 502340
  Instructor : Lamont M. Fulton

  More Trainings by this Expert


Overview:

The submission of a 505(b)(2) applications must be based on the presentation of required scientific evidence of safety and equivalency studies, These studies should show sameness of active ingredients between the proposed drug and the RLD. Thus, there must be a careful evaluation of any and all differences:

  • Formulation
  • labeling
  • conditions of use
  • bioequivalence and/or bioavailability

Why should you Attend: To understand the basis for FDA acceptance and rejection for 505 (b) (2) Application.

Thus, every applicant should know that the FDA generally will refuse to file a 505(b)(2) application for a drug that is a duplicate of a listed drug and eligible for approval under section 505(j) of the FD&C Act.

If FDA approves a pharmaceutical equivalent to a proposed product before a 505(b)(2) application is submitted, such that the proposed product would be a duplicate of that pharmaceutically equivalent drug product and therefore eligible for approval under section 505(j) of the FD&C Act, FDA will refuse to file the application as a 505(b)(2) application.

However, if FDA approves a duplicate drug product after a 505(b)(2) application is submitted but before the 505(b)(2) application is approved, that application would remain eligible for approval as a 505(b)(2) application, and FDA would not require the applicant of the pending 505(b)(2) application to withdraw the application and submit an ANDA.

While this presentation is not a comprehensive discussion of all the requirement listed in the guidance ("Guidance for Industry 505(b)(2) Application") it never the less focuses on the main aspects of concern.

Areas Covered in the Session:
  • Evaluation of 505(b)(2) Characteristic
    • Active ingredient
    • Dosage form
    • Route of administration
    • Strength
    • Indication
    • Conditions of use
  • A right of reference or use/ safety and/or effectiveness of listed drug
  • Bridge studies
  • 505(b)(2) application vs ANDA
  • Suitability Petitions

Who Will Benefit:
  • Regulatory Affairs Directors
  • Regulatory Managers, Associates
  • Regulatory Compliance Directors, Manager
  • Technical Services Mangers
  • Plant Manager
  • Materials Management
  • Quality Control Director, Manager


Speaker Profile
Mr. Lamont Michael Fulton is President of Regulatory Direction LLc and has over Forty years of Pharmaceutical experience (26 in regulatory affairs CMC).He has had roles as both Manager and Director of Chemistry Manufacturing and Controls (CMC) Regulatory and labeling at both Branded (Merck, SmithKline, Wyeth) and Generic drugs firm (Mylan). Prior to working as the leader to regulatory affairs departments, Mr. Fulton worked at the FDA as a Chemist reviewer in the center for drugs. While at the FDA, He also worked as an Analyst in the office of regulatory affairs and international office of policy, dealing with FDA/ICH regulations and guidance for global initiatives.

Mr. Fulton's past experience in government and industry, including his current role as senior consultant, has allowed him the opportunity to develop relationship with various CMC partners (Pfizer, Johnson and Johnson, Bristol Myers Squibb, etc.). It has also afforded his consultancy the chance to assist and manage other multidisciplinary teams achieve approval for dozens of NDA's, ANDA's to the FDA, as well as provide help with several successful international drug applications to the EMEA, MHLW and ROW. The blended years of both pharmaceutical quality and regulatory affairs has provided Mr. Fulton with a perspective to determine appropriate filing strategy and provide regulatory impact of changes in post Marketing products.

Mr. Fulton has BA degree in Chemistry from Cheyney University of Pennsylvania; where he studied under Dr.Taylor on the nature of terpenes and its various derivative. Certificate of Pharmaceutical training from University of Maryland school of Pharmacy / FDA program. Mr. Fulton's affiliations included; GPhA (Generic Pharmaceutical Association), ACS American chemical society) RAP (Regulatory Affairs Professional society), PDA (Parenteral Drug Association); Sigma Xi.




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