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  4. Guidance Development and Regulatory Assessment of Generic Topical and Dermal Drug Products - 10/03/2024
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Workshop | Virtual

Event Title
Guidance Development and Regulatory Assessment of Generic Topical and Dermal Drug Products
October 3, 2024

Date:
October 3, 2024
Time:
8:30 a.m. - 12:30 p.m. ET

Please Note: This workshop was previously advertised as a joint event between FDA and another organization. Edits have been made to this webpage to reflect that this is an FDA hosted event.

About the Event:

The Food and Drug Administration (FDA) proudly presents a virtual workshop on generic topical and dermal drug products. At this event, we will delve into the intricacies of generic topical and dermal drug products, addressing the challenges and opportunities in their guidance development, regulatory assessment, and approval.

Topical and dermal drug products, encompassing creams, ointments, lotions, gels, and patches, play a vital role in treating a wide range of skin conditions, from actinic keratosis to athlete's foot. Recognizing the significant impact of these products on public health, the FDA is committed to streamlining the regulatory process, ensuring the availability of high-quality, safe and effective generic topical and dermal drug products.

At this workshop, we will convene experts to share insights on product-specific guidance (PSG) development, research initiatives, bioequivalence and quality considerations, as well as case studies from generic drug application reviews of these drug products. Participants will engage in discussions on current regulatory thinking, challenges, and future directions for generic topical and dermal drug products.

Join us for this informative virtual workshop, as we work together to advance the development and approval of these generic drug products, ultimately enhancing patient access to high-quality, safe, and effective treatments.

Workshop Topics:

  • Development of PSG recommendations for topical and dermal drug products
  • Topical dermatologic corticosteroids: in vivo bioequivalence study guidance
  • Common deficiencies in topical and dermal products: IVRT, IVPT and beyond

Event Materials

Title File Type/Size
FDA Topical Drug Product Workshop Agenda pdf (165.31 KB)
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