BIO Comments on Benefit-Risk Assessments in Drug Regulatory Decision-Making
November 13, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making.
The benefit-risk framework is an important advancement in FDA product regulation because it reflects and reinforces the fact the FDA review process is grounded in the assessment of both benefits and risks. The FDA’s introduction and implementation of the structured benefit-risk framework has improved the transparency and communication of FDA’s decisions on approvals of new therapies. The framework has also allowed the FDA to share important information with the public about what to expect from approved therapies.
BIO supports FDA's continued efforts to evaluate and improve the clarity of the benefit-risk assessment process throughout the lifecycle of drug evaluation.
While the FDA benefit-risk framework has provided increased transparency and communication, additional work is needed in order to improve the framework. BIP provides recommendations for areas to continue to enhance the FDA’s benefit-risk framework, including transparency and flexibility of benefit-risk assessment in complete response letters, consistent use of the framework across review divisions, and including patient perspectives.
Download Full Comments Below
Benefit-Risk Assessments In Drug Regulatory Decision Making FDA-2017-N-4076
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making.
The benefit-risk framework is an important advancement in FDA product regulation because it reflects and reinforces the fact the FDA review process is grounded in the assessment of both benefits and risks. The FDA’s introduction and implementation of the structured benefit-risk framework has improved the transparency and communication of FDA’s decisions on approvals of new therapies. The framework has also allowed the FDA to share important information with the public about what to expect from approved therapies.
BIO supports FDA's continued efforts to evaluate and improve the clarity of the benefit-risk assessment process throughout the lifecycle of drug evaluation.
While the FDA benefit-risk framework has provided increased transparency and communication, additional work is needed in order to improve the framework. BIP provides recommendations for areas to continue to enhance the FDA’s benefit-risk framework, including transparency and flexibility of benefit-risk assessment in complete response letters, consistent use of the framework across review divisions, and including patient perspectives.