The US Food and Drug Administration (FDA) last week issued draft guidance that details its thinking on conducting product-specific guidance (PSG) meetings with generic drugmakers. The document is meant to reflect the agency’s commitment to increased communication under the latest generic drug user fee deal.
Almost five months after the Generic Drug User Fee Amendments (GDUFA III) were signed into law, FDA has published another guidance that addresses performance goals negotiated with industry. The draft guidance details the agency’s performance goals and how it plans to engage sponsors. (RELATED: FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III, Regulatory Focus 5 October 2022)
The guidance also sheds light on how regulators will determine the right types of meeting depending on the stage of the sponsors application and how it will address issues such as rescheduling meetings.
FDA said the guidance proposes procedures to promote well-managed PSG meetings and ensure that meetings are scheduled and conducted in accordance with the time frames it agreed to under the GDUFA III deal…
