How to Prepare for an FDA Meeting: FDA meeting basics for drug and biologics companies

Duration: 60 Minutes
Formal meetings with the reviewers of the US Food and Drug Administration (FDA) are perhaps one of the most important and useful resource available to the sponsors of medicinal products looking to get marketing approval in the US.
FDA meeting guidance
Instructor: Mukesh Kumar
Product ID: 500163
FDA personnel participate in hundreds of meetings each year with applicants for all kinds of applications submitted to the FDA. These meetings provide an opportunity to the industry to discuss product development strategies with the regulators and clarify interpretations of the regulations.

Why Should you Attend:
The ultimate goal of any product development is successful approval by the FDA. A given product could take up to 10 years and cost hundreds of millions of dollars before being ready for formal review by the FDA in a marketing application. For any product a sponsor needs to demonstrate safety, efficacy and consistency using a series of tests and process developments such as animal experiments, clinical trials, and optimizing the manufacturing steps. Moreover, each product has unique requirements for testing based on the scientific criteria to establish significant benefit over the risk of consumption.

Since FDA makes the final decision if the information provided in a given application is sufficient to approve or reject, it makes a lot of sense to discuss the contents with the FDA reviewer prior to submitting the formal application. One can get direct feedback from the FDA reviewers about the appropriateness of the proposed tests (animal and clinical trials), sufficiency of data and adequacy of the format in which the information is proposed to be presented. Sponsors can become aware of the FDA's concerns and opinions about all the tasks planned and completed, and help the applicant trouble-shoot issues before formal submission of data. The feedback obtained from the FDA reviewers could potentially help avoid pitfalls and preempt issues leading to higher probability of successful application.

FDA strongly recommends that the sponsor requests meeting with its reviewers as many times as needed and as early in development process as possible. FDA has released a few guidance documents to help sponsors prepare for these meetings and also published analysis by independent organizations highlighting the importance of pre-submission meetings with the FDA in getting faster and favorable response from the Agency. Periodic and timely discussions with the FDA have been shown to exponentially increase the probability of the rapid market approval for a given product. It has also been shown that most applications rejected by the FDA involved issues that could have been addressed relatively easily, with less time and cost, had the sponsors asked the right questions of the FDA reviewers.

The seminar will discuss the do's and don'ts of FDA meetings describing common mistakes and possible solutions using real-life case studies. Techniques in preparing for FDA meetings, from the initial request to close-out of discussions post-meeting will be described.

Learning objectives:
Learning how to make the most of meetings with FDA to achieve timely and cost-effective product development.

Objectives of the Presentation:
  • Types of FDA meetings
  • Key guidelines available from FDA
  • Preparing the meeting request
  • Preparing for the actual meeting
  • FDA's review process and sponsor consultation
  • Logistics of the FDA meeting
  • Follow-up to an FDA meeting
  • Do's and don'ts of an FDA meeting
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Project Managers
  • Clinical trial specialists
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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