BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance, Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.
BIO welcomes FDA’s recommendations to broaden eligibility criteria and increase enrollment of…
Letters, Testimony & Comments | September 27, 2019 | Drug Development Process, Drug Discovery, Regulatory Harmonization
BIO submitted comments to the Food and Drug Administration (FDA) on E19 Optimisation of Safety Data Collection; International Council for Harmonisation.
BIO welcomes this document on the optimization of safety data collection and supports the goal of internationally harmonized guidance on when it…
Letters, Testimony & Comments | April 15, 2019 | Human Health, Drug Development Process, Drug Discovery, Post-Approval Research
BIO submitted comments on the Food and Drug Administration (FDA)’s request for comments on safety labeling changes and implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.
The FDA’s statements and estimates refer exclusively to electronic labeling (e-Labeling). This…
Letters, Testimony & Comments | December 12, 2018 | Drug Development Process, Drug Discovery, Pre-Clinical Research, Clinical Research, Phase 1, Phase 2, Phase 3
BIO submitted comments on the Food and Drug Administration (FDA) Draft Guideline, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the…
Letters, Testimony & Comments | December 14, 2018 | Drug Development Process, Drug Discovery, Pre-Clinical Research, Clinical Research, Phase 1, Phase 2, Phase 3
BIO submitted comments to the Food and Drug Administration (FDA) following the public meeting, Patient-Focused Drug Development (PFDD) Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments.
BIO commends the FDA for…
Letters, Testimony & Comments | March 20, 2019 | Human Health, Reimbursement & Access, Medicare Part D, Out-Of-Pocket Costs
On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely concerned to see the Agency continue to focus on policy…
Letters, Testimony & Comments | March 20, 2019 | Human Health, Reimbursement & Access, Medicare Part D, Out-Of-Pocket Costs
BIO supports CMS’ commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment, particularly for prescription drugs and vaccines. To…
Letters, Testimony & Comments | April 2, 2019 | Human Health, Drug Development Process, Drug Discovery, Pre-Clinical Research, Clinical Research, Phase 1, Phase 2, Phase 3