| Don't Miss Out, Register Now for Generic Drug Development Webinars in August
FDA is hosting two webinars aimed at furthering generic drug product development, including:
- Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
Aug. 10, 2022 | 1 p.m. – 2:30 p.m. ET
On April 13, 2022, FDA published a draft guidance for industry titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. This webinar will take a deeper look at the draft guidance, expound on the Agency's recommendations to ANDA applicants regarding the submission and content of a waiver request for a difference in pH adjuster, and answer questions on the guidance.
- Best Practices for Topical Generic Product Development and ANDA Submission
Aug. 11, 2022 | 9:30 a.m. – 12:30 p.m. ET
In vitro studies that can support a demonstration of bioequivalence (BE) for topical generics typically include comparative physicochemical and structural (Q3) product characterization tests as well as in vitro release test (IVRT) and in vitro permeation test (IVPT) studies. This webinar will provide an overview of comparative Q3 characterization as well as IVRT and IVPT studies for topical generic drug product development and common deficiencies FDA has encountered in these studies. This webinar will highlight best practices and resources that FDA has developed and made publicly available to help generic drug applicants successfully implement efficient in vitro characterization-based BE approaches for topical generic products.
For both webinars there will be an opportunity for attendees to ask questions and get answers from FDA experts. For more information, including the full agenda and a list of presenters, please visit the web pages linked above.
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