BIO submitted comments on the Institute for Clinical and Economic Review (ICER) Value Assessment Framework. Throughout the attached letter, BIO addresses issues it has raised previously with the Framework as well as responds specifically to the four major categories of issues that the Institute…
Re: Draft Guidance for Industry: Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket No. FDA-2015-D-4750 (March 14, 2016))
The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit…
Letters, Testimony & Comments | August 8, 2016 | Medicaid
BIO submitted comments on the Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule, which focused on several proposals related to, among other things, CMS’s review of New Technology Add-on Applications, the Hospital Value-Based Purchasing Program, the Hospital Inpatient…
Letters, Testimony & Comments | July 19, 2016 | Human Health, Drug Development Process
Electronic health record (EHR) data and “real world evidence” generated from the post-marketing clinical use of medicines can provide valuable information regarding the use, benefits, or risks of therapies. BIO applauds FDA for taking steps to provide greater clarity around the use of EHR data in…
Letters, Testimony & Comments | July 19, 2016 | Biotechnology Innovation Organization (BIO), BIO Announcements, Human Health
BIO is supportive of FDA’s efforts to clarify the special protocol assessment (SPA) process for sponsors through the updated draft Special Protocol Assessment guidance, which provides helpful clarification on which protocols are eligible for SPA, as well as other updates and details.
BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BIO recognizes that access to medically-needed compounded medicines is highly important; but…
Letters, Testimony & Comments | June 23, 2016 | Biotechnology Innovation Organization (BIO), Human Health
Re: Docket No. FDA-2015-D-4848: Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity…
Letters, Testimony & Comments | June 23, 2016 | BIO Announcements, BIO Leadership, Human Health
Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016))
The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) draft guidance entitled …
Letters, Testimony & Comments | June 23, 2016 | Biotechnology Innovation Organization (BIO), BIO Announcements, Human Health
Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the…
Letters, Testimony & Comments | June 3, 2016 | Human Health
The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the Request for Information (RFI) Regarding Assessing Interoperability for MACRA (the “RFI”).1 BIO is the world's largest trade association representing biotechnology companies, academic…