BIO Comments on Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making
January 24, 2022
On Monday, January 24th, BIO submitted comments in response to the Food & Drug Administration’s (FDA) draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. Overall, BIO indicated that the draft guidance provides sponsors with helpful clarifications about the Agency’s expectations for providing high quality real-world data that are reliable and relevant for various types of clinical studies. In particular, BIO was pleased that the draft guidance underscores the principle of transparency in conducting real world data and evidence (RWD/E) studies that the entire research community can be held to, including pharmaceutical companies, health technology organizations, regulators, and academics. BIO applauds the level of detail within this guidance in setting clear parameters for the design and delivery of RWE for regulatory decision making. Lastly, BIO continues to stress the paramount importance of consistency and harmonization in the Agency’s use of RWD/E in regulatory decision making across all FDA product centers.
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Comments on RWD Assessing EHR and Medical Claims Data FDA
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On Monday, January 24th, BIO submitted comments in response to the Food & Drug Administration’s (FDA) draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. Overall, BIO indicated that the draft guidance provides sponsors with helpful clarifications about the Agency’s expectations for providing high quality real-world data that are reliable and relevant for various types of clinical studies. In particular, BIO was pleased that the draft guidance underscores the principle of transparency in conducting real world data and evidence (RWD/E) studies that the entire research community can be held to, including pharmaceutical companies, health technology organizations, regulators, and academics. BIO applauds the level of detail within this guidance in setting clear parameters for the design and delivery of RWE for regulatory decision making. Lastly, BIO continues to stress the paramount importance of consistency and harmonization in the Agency’s use of RWD/E in regulatory decision making across all FDA product centers.