BIO Comments on FDA Draft Guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics
November 28, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics: Draft Guidance for Industry, which provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials.
BIO says this important draft guidance will help companies use adaptive trial designs to provide evidence of the effectiveness and safety of a drug or biologic. BIO suggests additional information to include in the guidance as well as how to clarify the guidance.
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
In response to their advance notice of proposed rulemaking (ANPRM), BIO submitted comments to the DOJ's National Security Division on implementing the White House Executive Order of February 28, 2024, “Preventing Access to Americans’ Bulk Sensitive…
We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics: Draft Guidance for Industry, which provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials.
BIO says this important draft guidance will help companies use adaptive trial designs to provide evidence of the effectiveness and safety of a drug or biologic. BIO suggests additional information to include in the guidance as well as how to clarify the guidance.