BIO Comments on FDA Guidance: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
February 28, 2022
On Monday, February 28th, BIO submitted comments in response to the recent Food and Drug Administration (FDA) guidance for sponsors on designing or using an existing registry to support regulatory decision-making about a drug's effectiveness or safety. In addition to a number of specific line edits, BIO presented three key topics for the Agency to consider prior to the guidance’s finalization. First, BIO suggested that the Agency consider the feasibility of certain recommendations in situations where a sponsor is collaborating with a third-party registry holder such as an academic institution. For example, a drug sponsor working with an outside registry holder may be able to audit the registry holder’s processes for data quality but not usually the data themselves due to ethical and/or data privacy reasons. Secondly, BIO noted that it would be useful if the FDA provided additional clarity on which types of registries the guidance applies to. For example, Qualified Clinical Data Registries (QCDRs) that have been created to address CMS quality requirements and “registries” that have been developed via the integration of multiple sources of data, do not obtain patient consent nor are they assembled using a data collection/validation plan.BIO suggested this draft guidance document address only registries where patients are consented and enrolled for a specific purpose with a data collection plan. Lastly, BIO requested that the Agency provide more consistency on the topics covered across guidance documents.Topics that are likely relevant across RWD sources such as claims, EHRs, and registries (e.g., validation, linkage, hypothesis testing, provenance, etc.) are not treated equally across the guidance documents and may be a source of confusion for sponsors.
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BIO Comments on FDA Guidance: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
On Monday, February 28th, BIO submitted comments in response to the recent Food and Drug Administration (FDA) guidance for sponsors on designing or using an existing registry to support regulatory decision-making about a drug's effectiveness or safety. In addition to a number of specific line edits, BIO presented three key topics for the Agency to consider prior to the guidance’s finalization. First, BIO suggested that the Agency consider the feasibility of certain recommendations in situations where a sponsor is collaborating with a third-party registry holder such as an academic institution. For example, a drug sponsor working with an outside registry holder may be able to audit the registry holder’s processes for data quality but not usually the data themselves due to ethical and/or data privacy reasons. Secondly, BIO noted that it would be useful if the FDA provided additional clarity on which types of registries the guidance applies to. For example, Qualified Clinical Data Registries (QCDRs) that have been created to address CMS quality requirements and “registries” that have been developed via the integration of multiple sources of data, do not obtain patient consent nor are they assembled using a data collection/validation plan.BIO suggested this draft guidance document address only registries where patients are consented and enrolled for a specific purpose with a data collection plan. Lastly, BIO requested that the Agency provide more consistency on the topics covered across guidance documents.Topics that are likely relevant across RWD sources such as claims, EHRs, and registries (e.g., validation, linkage, hypothesis testing, provenance, etc.) are not treated equally across the guidance documents and may be a source of confusion for sponsors.