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BIO Comments Submitted to FDA on Regulation of LDTs

Feb 5 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (the "Notification Guidance) (Collectively the "LDT Guidance").

BIO Submits Comments on Draft Pregnancy and Lactation Labeling Guidance

Feb 1 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products.

BIO Submits Comments on DSCSA Standards for Interoperable Exchange

Jan 26 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on “The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information.”

BIO Submits Comments on DSCSA Standards for Interoperable Exchange

Jan 26 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on “The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information.”

BIO Signs Letter with Broad Coalition on Patent Litigation Reform

Jan 22 2015

BIO Submits Comments Regarding DRAFT 2016 Letter to Issuers in the Federally-facilitated Marketplaces

Jan 16 2015
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments regarding the Center for Medicare and Medicaid Services (CMS) Center for Consumer Information and Insurance Oversight’s (CCIIO’s) “Draft 2016 Letter to Issuers in the Federally-facilitated Marketplaces” published on December 19, 2014 (the “Draft Letter”).

BIO Submits Comments Regarding Health Benefit Plan Network Access and Adequacy Model Act

Jan 16 2015
The Biotechnology Industry Organization (BIO) appreciates this opportunity to submit the following comments on the National Association of Insurance Commissioners’ (NAIC’s) Health Benefit Plan Network Access and Adequacy Model Act #74 (“revised Model Act”).

BIO, PhRMA, and AdvaMed Submit Comments in response to Canada's WTO Notification

Jan 13 2015
On behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Advanced Medical Technology Association (AdvaMed), we hereby provide formal written comments in response to Canada's WTO notifcation

BIO Submits Comments Regarding HHS Notice of Benefit and Payment Parameters for 2016 Proposed Rule

Jan 6 2015
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments regarding the Department of Health and Human Services’ (HHS’s or the Department’s) Proposed Rule entitled “Notice of Benefit and Payment Parameters for 2016” published on December 8, 2014 (the “Proposed Rule”).

BIO Submits Comments on FDA-Sponsor Communication

Dec 28 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on “Best Practices for Communication Between the Food and Drug Administration and Investigational New Drug Sponsors During Drug Development.”