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Overview

Co-sponsored with the FDA.

Complex Generic Drugs are a large and diverse group of products with complex active ingredients or sites of action and complex drug-device combination products. They provide important therapies to patients, for example, metered dose inhalers for treating asthma and drugs administered by auto-injectors and prefilled syringes. Because this diverse collection of drug products has one or more elements that are more complex than a simple dosage form, new complexities in the methodologies used for establishing bioequivalence are introduced, thus impeding patient access to the more affordable generic versions of these life-saving medicines.

In 2017, the FDA announced the Drug Competition Action Plan to advance new policies aimed at bringing more competition to the drug market to help reduce drug prices and improve consumer access to these much-needed medicines. The intent is to improve the efficiency of the generic drug approval process and make it easier to bring generic competition to this important category of branded drugs known as complex drugs.

Knowing that the scientific and regulatory pathways for approval of generic versions of complex products are not always well- known to generic developers, FDA intends through its policies to provide as much scientific and regulatory clarity as possible with respect to complex generic drugs. This meeting will address complex drug-device combination products, examining the science of medical device impact on drug bioequivalence in products where the drug is the primary mode of action (PMOA). The impact of devices such as auto injectors, prefilled syringes, inhalant devices, implanted delivery systems, transdermal systems, and others will be explored. The intersections of drug and device regulatory pathways and policies relating to bioequivalence studies will also be reviewed.

Join FDA staff from the CDER Office of Generic Drugs (OGD), the Office of Pharmaceutical Quality (OPQ), CDRH, the Office of Combination Products (OCP), and industry experts to discuss the knowns, unknowns, and the role of modeling in the development of these important products.


NEW! Travel Once, Save Twice!
This year, DIA's Complex Drug-Device Generic Combination Products Meeting will be co-located with DIA's Combination Products Conference. Maximize your education and time by attending both! Save* $100 when you register for both events!
*You must register for both events at the same time for the discount to be applied.

Exclusive Podcast

Take a listen to our podcast with Maryll Toufanian, Acting Director, US FDA Office of Generic Drug Policy. “In order for FDA to approve a generic drug, a generic manufacturer must submit scientific information supporting the generic drug’s ‘sameness’ to the brand.”

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Additional Resources - On-Demand Generics Webinar Series

Who should attend?

Professionals involved in:

  • Biopharmaceutical, Device, and Combination Product R&D and Development
  • Generics Development
  • Clinical Research
  • Pharmacology
  • Regulatory Affairs
  • Safety/Pharmacovigilance
  • Quality Assurance and Control
  • CMC/GMP
  • Policy
  • Consulting, Legal, Government Affairs
  • Business Development

Learning objectives

At the conclusion of this Meeting, participants should be able to:

  • Explore the statutory framework and associated regulatory and policy considerations for drug-device combination products submitted in an ANDA
  • Identify and address scientific considerations for establishing bioequivalence for different complex drug-device combination delivery methods
  • Identify specific product quality challenges in developing different approaches to drug-device combination product manufacturing to meet sameness in product performance and cGMP requirements
  • Discuss ideas for improving communication and collaboration between industry, academia, and the agency in developing novel methods and standards for assessing the sameness of complex generic drug-device combination products

Program Committee

  • Markham  Luke, MD, PhD
    Markham Luke, MD, PhD Director, Division of Therapeutic Performance, Office of Generic Drugs,CDER
    FDA, United States
  • Andrew A. LeBoeuf, JD, MS
    Andrew A. LeBoeuf, JD, MS Regulatory Counsel, Office of Generic Drug Policy, CDER
    FDA, United States
  • Patricia Y. Love, MD, MBA
    Patricia Y. Love, MD, MBA Deputy Director, Office of Combination Products, OSPM, OMPT
    FDA, United States
  • Brian  McCormick
    Brian McCormick Vice President - Chief Regulatory Counsel
    Teva Pharmaceuticals, United States
  • John  Peters, MD
    John Peters, MD Deputy Director, Office of Generic Drugs, CDER
    FDA, United States
  • Susan M. Rosencrance, PhD
    Susan M. Rosencrance, PhD Director, Office of Lifecycle Drug Products, OPQ, CDER
    FDA, United States
  • Alan  Stevens, MS
    Alan Stevens, MS Branch Chief, General Hospital Devices Branch, ODE, CDRH
    FDA, United States
  • Roisin   Wallace
    Roisin Wallace VP, Head of Global Device Development
    Mylan, Ireland
  • John Barlow Weiner, JD
    John Barlow Weiner, JD Associate Director for Policy, Office of Combination Products, OSMP
    FDA, United States
  • Kimberly  Witzmann, MD
    Kimberly Witzmann, MD Division of Therapeutic Performance, Office of Generic Drugs, CDER
    FDA, United States
  • Jason  Woo, MD, MPH
    Jason Woo, MD, MPH Senior Medical Officer, Office of Generic Drugs, CDER
    FDA, United States
  • Geoffrey  Wu, PhD
    Geoffrey Wu, PhD Associate Director, OLDP, OPQ, CDER
    FDA, United States
  • Lei  Zhang, PhD
    Lei Zhang, PhD Deputy Director, Office of Research & Standards, Office of Generic Drugs, CDER
    FDA, United States
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Co-Located Conference

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