PFDD: BIO Comments on FDA Draft Guidance Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

September 11, 2018


BIO Announces Programming for the 17th Annual BIO Investor Forum

Amidst a healthy investment climate for biotech companies, BIO announces programming for the 17th annual BIO Investor Forum

BIO Urges EPA to Help Boost America’s Rural Economy

On Friday, August 17, the Biotechnology Innovation Organization (BIO) urged the Environmental Protection Agency (EPA) to use its authority under the Renewable Fuel Standard (RFS) program to strengthen America’s biobased economy.

BIO Comments on RFS Standards for 2019 and Biomass-Based Diesel Volumes for 2020

The Biotechnology Innovation Organization (BIO) is pleased to provide comment on the U.S. Environmental Protection Agency’s (EPA’s) proposed rule on the Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020 (proposed rule).

BIO Submits Comments on FDA Draft Guidance: Limited Population Pathway for Antibacterial and Antifungal Drugs

Re: Docket No. FDA-2018-D-2032: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD); Draft Guidance for Industry.”  

BIO Releases Statement on NGA’s Report on Prescription Drug Costs

Washington, DC (August 10, 2018) – Tom Dilenge, president of advocacy, law & public policy at the Biotechnology Innovation Organization (BIO), issued the following statement today after the National Governors Association (NGA) released a report outlining “potential state strategies” to address prescription drug costs...

Biofuel and Agriculture Groups Petition to EPA regarding Lost RFS Volumes from Small Refinery Exemptions

RE: Petition for Reconsideration of 40 C.F.R. §80.1405(c), EPA Docket No. EPA–HQ–OAR–2005–0161, promulgated in 75 Fed. Reg. 14,670 (Mar. 26, 2010); Petition for Reconsideration of Periodic Reviews for the Renewable Fuel Standard Program, 82 Fed. Reg. 58,364 (Dec. 12, 2017)

Pediatrics: BIO Comment on FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

August 3, 2018


BIO Led Coalition Letter in Support of Cellulosic Biofuel Technologies

As the U.S. Environmental Protection Agency (EPA) begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), we encourage the agency to take a renewed look at commercial-ready cellulosic biofuels.

Congressman Tom Suozzi to Spotlight Scientific and Economic Development Advancements in New York

Congressman Tom Suozzi will join leaders of New York’s biotechnology community for a tour of Alexandria LaunchLabs on Monday, July 30, 2018 at 11:00 am.