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DoD Medical Countermeasure Systems Industry Day

Jul 1 2015
On June 15, 2015, the Department of Defense's (DoD's) Joint Project Manager-Medical Countermeasure Systems (JPM-MCS) held a co-located Industry Day in conjunction with the BIO Convention in Philadelphia, Pennsylvania. The MCS Industry Day focused on industry feedback related to the DoD's proposed use of an Other Transaction Authority (OTA) contracting mechanism. 

BIO and PhRMA Submit Joint Comments to FDA on the Interim Assessment of the NME Review Program

Jun 23 2015
The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) submit these comments in response to the Federal Register notice entitled “Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket” issued by the U.S. Food and Drug Administration (FDA).

BIO Submits Comments on Draft PDUFA Meetings Guidance

Jun 8 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the revised draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.”

Letter to Senate Judiciary Committee on Managers Amendment to PATENT Act

Jun 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.

Letter to Senate Judiciary Committee on Managers Amendment to PATENT Act

Jun 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.

BIO'S Letter to House Appropriations Agriculture Committee re Section 9003 of the Agricultural Act of 2014

May 21 2015
On behalf of the biotechnology industry we are writing to encourage your support of full funding of Section 9003 of the Agricultural Act of 2014 (Public Law 113-79), the Biorefinery, Renewable Chemical, and Biobased Manufacturing Assistance Program, as you develop the Fiscal Year 2016 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act.

BIO Comments on FDA Draft Guidance: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application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BIO applauds the issuance by the Food and Drug Administration (FDA) of the Draft Guidance entitled, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”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.