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BIO Submits Comments on the Establishment of CDRH PEAC

Nov 19 2015
The Biotechnology Industry Organization (BIO) thanks the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) for the opportunity to submit comments to the public docket entitled Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments1 (the “Public Docket”).

BIO Submits Comments Re: 340B "Mega" Guidance

Oct 30 2015
The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to submit the following comments in response to the proposed Notice, issues by the Health Resources and Services Administration (“HRSA”) and published in the Federal Register on August 28, 2015, entitled 340B Drug Pricing Program Omnibus Guidance [RIN-9096-AB08] (“Proposed Notice”).

BIO Submits Comments to OIRA Re: Enrollment and Re-certification of Entities in the 340B Program

Oct 30 2015
The Honorable Howard A. Shelanski Administrator Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW Washington, DC 20503   BY ELECTRONIC SUBMISSION   Re: Information Collection Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327—Revision]   Dear Administrator Shelanski:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Office of Information and Regulatory Affairs (OIRA) in response to the Health Resources and Services Administration’s (HRSA’s) proposed Information Collection Notice entitled “Proposed Collection Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Price Calculations”1 (the “Notice”). BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.

BIO Submits Comments to HRSA Re: Enrollment and Re-certification of Entities in the 340B Program

Oct 30 2015
CDR Krista M. Pedley, PharmD, MS, USPHS Director Office of Pharmacy Affairs Healthcare Systems Bureau Health Resources and Services Administration 5600 Fishers Lane Parklawn Building, Room 10C-03 Rockville, MD 20857 Re: Agency Information Collection Activities: Proposed Collection: Comment Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Price Calculations (OMB No. 0915-0327-[Revision]) Dear Commander Pedley: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments in response to the Health Resources and Services Administration’s (HRSA’s) proposed Information Collection Notice entitled “Proposed Collection: Comment Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Price Calculations” (the “Notice”).  BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in the United States and around the globe. BIO members are involved in the research and development of healthcare, agricultural, industrial, and environmental biotechnology products.  

BIO Comments on the July 2015 Update on Subject Matter Eligibility

Oct 29 2015
The Biotechnology Industry Organization (BIO) appreciates this opportunity to submit comments on the United States Patent and Trademark Office’s (USPTO) July 2015 Update on Subject Matter Eligibility (Guidance).

BIO Submits Comments Re: USDA-APHIS Changes to Requirements for Field Testing Regulated Genetically Engineered Wheat

Oct 27 2015
The Biotechnology Industry Organization (BIO) is pleased to submit these comments in response to the USDA Animal and Plant Health Inspection Service (APHIS) notice requesting public input on proposed changes to requirements for field testing of regulated genetically engineered (GE) wheat (Notice). BIO is the world's largest trade association, representing more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products, and BIO represents the majority of the biotechnology product developers in North America, including companies conducting field trials of GE wheat.

BIO Submits Comments on Nonproprietary Naming of Biological Products

Oct 26 2015
The Biotechnology Industry Organization (“BIO”) thanks the Food and Drug Administration (“FDA”) for the opportunity to submit comments on the Draft Guidance entitled “Nonproprietary Naming of Biological Products” (“Draft Guidance”).

BIO Submits Comments Re: FDA Rare Diseases Guidance

Oct 22 2015
RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry, entitled “Rare Diseases: Common Issues in Drug Development” (Draft Guidance).   BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO, ABA Members Weigh in on Coordinated Framework

Oct 21 2015
We are writing to express our appreciation for the guidance and opportunity for input provided by the Request for Information (RFI) on the White House initiative to review and assess the Coordinated Framework (CF). We strongly support this one-year initiative and its objectives: to ensure public confidence in the regulatory system and prevent unnecessary barriers to future innovation and competitiveness, while continuing to protect health and the environment.

BIO Submits Comments on Draft Testicular Toxicity Guidance

Oct 14 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 Testicular Toxicity: Evaluation During Drug Development