FY 2018 Generic Drug Regulatory Science Initiatives Public Workshop May 24, 2018

Workshop | In Person

• Date: May 24, 2018

• Organized By: Office of Generic Drugs

Meeting Information

Date:

Thursday, May 24, 2018, from 8:30 - 4:30pm

Location:

FDA White Oak Campus, 10903 New Hampshire Ave. Bldg. 31, Rm. 1503 Sections B&C Silver Spring, MD 20993

Background:

FDA will hold a public workshop that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties––as it fulfills its commitment under the reauthorization of the Generic Drug User Fee Amendments (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2019 Regulatory Science Plan. 

The workshop will be held on May 24, 2018, at the FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Great Room Sections B & C, Silver Spring, MD 20993. Additional details are available in the Federal Register Notice.

FDA wants your input. Electronic or written comments will be accepted at any time until the docket closes on June 25, 2018. You may also submit ideas on generic drug research topics to be included on the FY 2018 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.

Registration:

If you wish to attend (either in person or by Webcast), please send an email to GDUFARegulatoryScience@fda.hhs.gov The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number and whether you will be attending in person or by webcast).

Meeting Materials:

• Transcript
• Webcast
• Federal Register Notice
• Agenda (Final) 
• Panel List (Final)
• Public Comment Period Presenters (PDF - 34KB)
• Part 1: https://collaboration.fda.gov/p1z94u60vs1
• Part 2: https://collaboration.fda.gov/p6k2yw04ehg
• Part 3: https://collaboration.fda.gov/p5iv2jz72li
• Part 4: https://collaboration.fda.gov/p7k8l1imqc8

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FY 2018 Generic Drug Research Public Workshop Presentations
Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance.

Introduction

• Opening Remarks,  Robert Lionberger, FDA (PDF - 100 KB) 
• FDA Research Update on the FY18 Initiatives, Lei Zhang, FDA  (PDF - 573KB)
• Research Metrics for GDUFA II Mandated Outcome Reporting, Stephanie Choi , FDA (PDF - 466KB)

Session I: Evaluation of FY 18 Generic Drug Research Priorities

• Complex Drug Products, Theofanis Mantourlias, Fresenius Kabi Austria (PDF - 1 MB)
• Inhalation Drug Products, Prasad Peri, Teva (PDF - 690 KB)
• Topical Products: When Does a Difference Matter? Michael Roberts, University of South Australia, University of Queensland (PDF - 2MB)
• What are the Knowledge Gaps that Need to be Filled Before One Can Approve Generic Inhalation Drugs on In Vitro and PK Studies Alone? Guenther Hochhaus, University of Florida (PDF - 549 KB)
• Challenges in BCS-based biowaivers, James Polli, NIPTE and University of Maryland School of Pharmacy (PDF - 395 KB)
• Bioassays for Establishing Equivalence; Linking API and Formulation to their Biological Effect, Sid Bhoopathy, Absorption Systems (PDF - 635 KB)
• Non-Clinical Tools For In Vitro-In Vivo Correlation (IVIVC) and Bioequivalence Assessment of Ophthalmic Products, Vatsala Naageshwaran, Absorption Systems (PDF - 804 KB)
• Critical issues in the use and evaluation of excipients in dosage forms such as pediatric, geriatric and abuse deterrent dosage forms, Stephen W. Hoag, NIPTE and University of Maryland (PDF - 553 KB)
• Advances in BA/BE and Dissolution Methodology, Gordon Amidon, University of Michigan (PDF - 2 MB)

Session I: Evaluation of FY 18 Generic Drug Research Priorities

• Potential Research Challenges for Newly Approved Complex RLDs, Xiaohui Jiang, FDA (PDF - 878 KB)
• Individual Physiology, Biology, Anatomy and Their Interplay with Formulation: Impossible Permutations of Conditions to be Studied for Bioequivalence, Amin Rostami, Certara, University of Manchester (PDF - 2 MB)
• Challenges in Safety Surveillance for Generic Drugs, Howard Chazin, FDA (PDF - 368 KB)
• Off-Label Use of Generic Drugs in Pediatric Populations, Ilene Harris, IMPAQ International, LLC (PDF - 287 KB)
• Enhancing Comprehension of Generic Drug Information among Patients and Caregivers with Low Health Literacy, Jingjing Qian, Auburn University Harrison School of Pharmacy (PDF - 286 KB)
• A Model- and Systems-Based Approach to Efficacy and Safety Questions Related to Generic Substitution, Stephan Schmidt, University of Florida (PDF - 1 MB)
• Anticipated Regulatory Science Challenges in Democratizing Generic Drugs for Global Health, Eugene Choi, Virginia Commonwealth University (PDF - 1 MB)
   

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Event Materials

Title	File Type/Size
FDA GDUFA Public Workshop Full Transcript 05-24-17	pdf (781.39 KB)