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Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Bio

Dec 1 2015
Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology.

Quality Metrics: BIO Comments on FDA Draft Guidance Request for Quality Metrics

Nov 23 2015
In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. It would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry. We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.

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.