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BIO Comments on FDA Draft Guidance: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

May 19 2015
BIO applauds the issuance by the Food and Drug Administration (FDA) of the Draft Guidance entitled, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” (Draft Guidance)1 The policies and recommendations set forth in the Draft Guidance, when finalized, represent critical steps forward in the effort to protect patients from biological products prepared under conditions that could result in their contamination or a lack of effectiveness.

BIO Submits Comments on Electronic Distribution of Prescribing Information NPRM

May 17 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Proposed Rule entitled “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products.”

BIO Submits Comments Re: CMS HCPCS Public Meeting

May 8 2015
The Biotechnology Industry Organization (BIO) is pleased to provide comments in response to the May 7 Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals (“Public Meeting Agenda”).

BIO Comments to the EPA RVOs Docket ID No EPA-HQ-OAR-2013-0479

May 8 2015
The Biotechnology Industry Organization (“BIO”) is pleased to have the opportunity today to comment on the U.S. Environmental Protection Agency’s (“EPA”) Proposed Rule on the 2014 Standards for the Renewable Fuel Standard (RFS) PrograM (“the proposed rule”) and the renewable volume obligations (RVO) for biofuels in 2014.

Shane Kovacs Executive Vice President & Chief Financial Officer, PTC Therapeutics, Inc.

Apr 30 2015
On behalf of the Biotechnology Industry Organization Before the United States House of Representatives Committee on Financial Services, Subcommittee on Capital Markets and Government Sponsored Enterprises --- Legislative Proposals to Enhance Capital Formation and Reduce Regulatory Burdens

Coalition for Safe and Affordable Food's Letter to House of Representatives re H.R. 1599, the Safe and Accurate Food Labeling Act

Apr 29 2015
We are writing on behalf of the Coalition for Safe and Affordable Food about a significant development that could impact American consumers, businesses, farmers and food manufacturers. At a time when legislative consensus is hard to come by, it is notable that substantial bipartisan support is building behind a national, voluntary food labeling standard for products containing ingredients derived from genetically modified organisms (GMOs).

U.S. Biotech Crops Alliance's Letter to European Commission Re Regulatory Procedure for Importing Biotech Products

Apr 28 2015
Dear Commissioner Andriukaitis, On March 12, 2015 the undersigned organizations, representing a broad section of the U.S. food and agricultural industry, provided comments on the review of the European Union's (EU) regulatory procedure for approving the import of new biotechnology products being conducted by DG SANTE. In our letter we stated that a number of core principles and commitments must result from this review (see attachment).

BIO Submits Comments to FDA on Pediatrics Stakeholders Meeting

Apr 23 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to present our views on pediatric drug development at the March 25 pediatric stakeholder meeting and to submit written comments to the docket. BIO applauds the leadership of the FDA for convening the stakeholder meeting to help foster collaboration and coordination across all pediatrics stakeholders, including industry, academia, the patient advocacy community, and government, so that we can work together to develop safe and effective new therapies for children.

BIO Files Amicus Brief in Amgen v. Sandoz

Apr 23 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case.

BIO Submits Comments to FDA on Next Generation Sequencing

Apr 20 2015