Letters, Testimony & Comments

BIO submits specific comments and recommended edits on the draft guidance 2016-D-0643

BIO joins 30 other national trade associations in speaking out against unprecedented and burdensome FTC-DOJ regulation of mergers

BIO joined other stakeholders to urge Congressional leaders to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA).

BIO and BIO members are urging lawmakers to enact a short-term extension of the MCM-PRV program while Congress is waiting to address a full reauthorization with PAHPA.

To protect patient access to critical prescription drugs, BIO has identified Part D guardrails (both MA-PD and PDP) for consideration as CMS develops guidance to plans for CY2025 and beyond.

BIO and PhRMA submitted joint comments on the U.S. Food and Drug Administration’s Information Technology Strategy (Docket No. FDA-2023-N-3636)

BIO submits comments and specific recommendations to the U.S. Food and Drug Administration on their Draft Guidance for Industry (Docket No. FDA-2023-D-2436)

On behalf of CSBA, BIO submitted this MDRP sign-on letter to CMS, which strongly urged the agency to refrain from finalizing a proposal that would drastically impact the Medicaid Best Price calculation.

BIO submitted comments to the National Institutes of Health in response to the agency's request for comment on a proposal to review NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to include specific…

In response to their request for information, BIO submitted these comments, including line-by-line recommended edits.