FDA Grand Rounds

 

 

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The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.

The next FDA Grand Rounds is scheduled for October 8, 2020. (Webcast only)

FDA Grand Rounds: Bioequivalence of Complex Topical Generics: In Vitro and In Vivo

Thursday, October 8, 2020
12:00 p.m. - 1:00 p.m. EST
Webcast Only

Presented by:

Sam Raney, PhD
Lead for Topical and Transdermal Drug Products
Office of Generic Drugs, CDER
US Food and Drug Administration

About the Presentation:

This presentation summarizes a series of FDA-coordinated, GDUFA-funded research studies included in a strategic multi-year, multi-million dollar research program to develop new, more efficient approaches by which to evaluate bioequivalence (BE) for topical generics. These studies characterized solution, gel, ointment, lotion and cream topical products containing a range of drugs including acyclovir, metronidazole, nystatin, triamcinolone acetonide, lidocaine, prilocaine, and diclofenac.

Frequently, BE assessments with the same set of products are conducted in vitro and in vivo, under matched conditions. In vitro studies typically include physical and structural (Q3) product characterizations as well as in vitro release (IVRT) and in vitro permeation test (IVPT) studies. In vivo BE studies utilize pharmacokinetic endpoints (e.g., dermal micro dialysis) or clinical endpoints. Collectively, the results of such research have established a remarkably clear, consistent, and substantial body of evidence supporting the utility of sensitive and efficient in vitro BE methods for topical products as an alternative to (or in support of) an in vivo BE assessment.

Based upon this research program, revolutionary new paradigms have been developed to establish topical BE more efficiently via in vitro BE and cutaneous PK approaches, which can be more accurate, sensitive and reproducible than traditional BE approaches for topical products. These advances have enabled FDA to be responsive to numerous product development communications with prospective generic drug applicants, through controlled correspondences, Pre-ANDA meeting requests, product-specific guidances, and internal consultations with review divisions which have directly supported the review (and approval) of ANDAs submitted to the FDA involving novel BE approaches

Past Grand Rounds

2020

• Advancing the Science of Real-World Data to Address the COVID-19 Pandemic
• Nanotechnology: Over a Decade of Progress and Innovation at FDA
• A Pandemic and a Call to Action for One Health: The FDA One Health Initiative
• Artificial Intelligence for Regulatory Science Research
• Analysis of Per and Polyfluoroalkyl Substances (PFAS) in foods- Analytical method development, challenges and successes
• Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology
• Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays
• Quality Control: Stopping infections before they happen through safer endoscope reprocessing

2019

• Vet-LIRN – How FDA’s Network of Veterinary Diagnostic Laboratories advance animal food safety and public health by conducting outbreak investigations and monitoring resistance in animal pathogens
• Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices

• Why FDA authorized the marketing of the IQOS heated tobacco product as “appropriate for the protection of the public health”

• Overview of FDA's Perinatal Health Center of Excellence: Development and Validation of Predictive Systems

• Cyclospora Cayetanensis: The Crossroads Between Scientific Advances and Knowledge Gaps 

• Gaining Insight into the Patient’s Experience by Harnessing the Power of Social Listening and FDA Archival Data 

• Uncertainty is the only certainty there is: Potential approaches for making public health decisions

• The VICTRE trial: an in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography

2018

• Jerky Pet Treats and illness in dogs:  a collaborative approach to investigating a mysterious outbreak
• Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling
• The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes
• Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments
• How Simulation Can Transform Regulatory Pathways
• FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders
• Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine
• Ethnicity- and Gender-Related Differences in Alzheimer's Disease

2017

• Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies
• Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
• Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health
• Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads
• Vaccine adjuvants: New ways to evaluate their safety and effectiveness
• Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products

2016

• The Host Response to Whooping Cough Infection and Vaccination [Archived]
• Antibiotic resistance surveillance in the age of genomics: New answers to old questions [Archived]
• FDA Research into 3D Printing of its Regulated Products [Archived]
• Rapid Screening of Dietary Supplements for Undeclared Ingredients [Archived]
• Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity Studies [Archived]

Resources For You

• FDA's Predictive Toxicology Roadmap
• Don't Miss the CDC Public Health Grand Rounds