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ABOUT THIS WEBINAR

On April 13, 2022, FDA published a draft guidance for industry titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. This draft guidance is intended to assist Abbreviated New Drug Application (ANDA) applicants that reference a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the RLD with respect to a pH adjuster(s).

This draft guidance identifies the type of information FDA may generally consider in evaluating a waiver request for pH adjusters in generic drug products intended for parenteral, ophthalmic, or otic use and provides recommendations to ANDA applicants regarding the submission and content of such a waiver request. This draft guidance may help to streamline the drug development process for applicants by enabling flexibility in the regulatory requirements for how a particular applicant meets the statutory standards for approval.

This webinar will take a deeper look at the draft guidance, expound on the Agency’s recommendations to ANDA applicants regarding the submission and content of such a waiver request, and answer questions submitted to the Federal Register Notice.

LEARNING OBJECTIVES

• Provide an overview of the draft guidance for industry
• Provide clarification and rationale for the Agency’s recommendations for applicants requesting 314.99(b) waivers for Q1/Q2 differences in pH adjuster between the proposed and RLD formulations and FDA’s waiver request evaluation process
• Address questions submitted to the Federal Register Notice

INTENDED AUDIENCE

• Generic drug industry, including current and potential generic drugs applicants
• Regulatory reviewers and policy makers for generic drug development and assessments

FDA SPEAKERS

Darby Kozak, PhD
Deputy Director
Division of Therapeutic Performance (DTP) | Office of Research and Standards (ORS) | Office of Generic Drugs (OGD)

Hee Sun Chung, PhD
Lead Pharmacologist
Division of Bioequivalence I (DBI) | Office of Bioequivalence (OB) | OGD

Amanda Jones, PhD
Lead Pharmacologist
DBI | OB | OGD

FDA PANELISTS

Darby Kozak, Hee Sun Chung, and
Utpal Munshi, PhD
Director
DBI | OB | OGD

Melissa Mannion, PharmD, JD
Regulatory Counsel
Division of Policy Development (DPD) | Office of Generic Drug Policy (OGDP) | OGD

Truong-Vinh (Vinh) Phung, PharmD
Supervisory Pharmacist
Division of Filing Review (DFR) | Office of Regulatory Operations (ORO) | OGD

Brittany Avaritt, PhD
Pharmacologist
Division of Regulations, Guidance, and Standards (DRGS) | Office of Policy for Pharmaceutical Quality (OPPQ) | Office of Pharmaceutical Quality (OPQ)

Bing Cai, PhD
Director
Division of Liquid-Based Products I (DLBP I) | Office of Lifecycle Drug Products (OLDP) | OPQ

FDA Resources

• Federal Register Notice
• Direct link to guidance

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course is:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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