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Pennsylvania Governor Wolf Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines

BIO and Pennsylvania Bio commend Governor Tom Wolf for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.

Electronic Health Record Data: BIO Comments on FDA Draft Guidance Use of Electronic Health Record Data in Clinical Investigations

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 clinical assessments of safety and effectiveness in regulatory submissions.

SPA: BIO Comments on Special Protocol Assessment; Draft Guidance for Industry

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.

Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).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 access cannot and should not come at the expense of product quality and patient safety.

BIO Statement on Prescription Drug User Fee Act Goals Letter

Washington, D.C. (July 15, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding the Prescription Drug User Fee Act (PDUFA) VI goals letter:

BIO and Nikon Instruments Inc. Jointly announce a new Program for Research Grade Microscope System for BIO Members

BIO and Nikon Instruments Inc. jointly announce a new partnership under the BIO Business Solutions® offerings.

BIO Applauds Advancement of H.R. 3299

Statement on House Energy & Commerce Committee Passage of H.R. 3299, the Strengthening Public Health Emergency Response Act of 2016

BIO Applauds Passage of Federal Approach to GMO Disclosure

Washington, D.C. (July 14, 2016) – The Biotechnology Innovation Organization (BIO) welcomes Congressional passage of a federal, uniform approach to GMO disclosure.   

BIO Comments on Renewable Fuel Standards for 2017

BIO urges EPA to get the RFS back on track with a commitment to stable implementation of the program that tracks statutory requirements. In particular, we urge EPA to account more appropriately for the availability of advanced and other biofuels to meet statutory volume requirements, and to make significant changes to EPA’s proposed reductions in volume requirements for advanced biofuel, cellulosic biofuel, and total renewable fuel.

BIO Submits Comments on Proposed 2017 Renewable Fuel Standards

BIO today submitted comments on EPA's proposed Renewable Fuel Standards for 2017, demonstrating that EPA’s interpretation of statutory waiver authority is flawed and its proposed volumes of renewable fuel available for the program are too low and should be revised upward.