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BIO Comments to the California Air Resources Board On the Low Carbon Fuel Standard

Feb 19 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments to the California Air Resources Board (CARB) on the Low Carbon Fuel Standard (LCFS) readoption plan (the readoption plan, or the plan). 

BIO Submits Comments on Rare Pediatric Disease Priority Review Vouchers

Feb 12 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry entitled “Rare Pediatric Disease Priority Review Vouchers.”

BIO 2015 Special 301 Submission

Feb 9 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR) efforts in preserving strong intellectual property protections for United States’ companies internationally. BIO appreciates the opportunity to comment on 2015 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.

BIO Submits Comments on Pediatrics Clinical Pharmacology

Feb 8 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.”

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The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products.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”).