The US FDA has issued draft guidance on the formal meetings between the FDA and sponsors or applicants of PDUFA products. The industry needs to revert to the global regulator by June end.
This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Commenting from an Indian pharma industry perspective, Kaushik Desai, pharma consultant and Hon. General Secretary, Indian Pharmaceutical Association said that the draft had brought in considerable clarity for the pharma industry to iron out issues with the regulator. This is also a platform which Indian pharma industry needs to take advantage to put forth its views and arrive at a positive outcome. It would put the industry in a win-win situation.
“Further in the wake of the growing significance of generic drugs driven by its affordability factor, the prescription pharmaceuticals are seen to be the future. By 2020, biological drugs would gain momentum because they are seen to be answer to targeted therapies for critical diseases. Going the research efforts of pharma companies, the formal meetings between the FDA and industry are seen to be a step in the right direction, adds Desai.
The regulations do not apply to abbreviated new drug applications (ANDA), applications for biosimilar biological products and submissions for medical devices. For the purposes of this guidance, formal meeting includes those requested by a sponsor or applicant which could be conducted in any format: face to face, teleconference, videoconference, or written response. It discusses the principles of good meeting management practices (GMMPs) and provides standardised procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.
This guidance revises the guidance for industry formal meetings between the FDA and sponsors or applicants issued in May 2009. Once After finalised, it will replace the May 2009 guidance. The updation is in accordance with meeting management goals section of the Prescription Drug User Fee Act (PDUFA) reauthorization performance goals and procedures for the fiscal years between 2013 and 2017.
Significant changes from the 2009 version include: Addition of the written response meeting format for pre-investigational new drug application (pre-IND).
Designation of a post-action meeting requested within 3 months for an FDA regulatory action other than approval. It could also be for meetings regarding risk evaluation and mitigation strategies (REMS) or post marketing requirements that occur outside the context of the review of a marketing application.
Each year, FDA review staff participation in many meetings with requesters who seek advice relating to the development and review of investigational new drugs and biologics, or biological product marketing applications.
Since these meetings often represent critical points in the regulatory process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings. The GMMPs in this guidance are intended to provide consistent procedures that will promote well-managed meetings and to ensure that these are scheduled within a reasonable time, conducted efficiently, and documented appropriately.
The FDA intends to schedule meetings to occur within 60 days of its receipt of the written meeting request. If a request is for a meeting date that is beyond 60 days from the date of request receipt, the meeting date should be within 14 calendar days of the requested date.