Letters, Testimony & Comments

October 14, 2014
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #8 published by the Brazilian Ministry of Health on August 14, 2014 which proposes a new regulation defining the guidelines and...
October 14, 2014
The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin, and we...
October 14, 2014
Dear Sir/Madam:   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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Clinical Pharmacology Labeling for Human...
October 1, 2014
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) proposed rule regarding the payment policies under the physician fee schedule (PFS) and other...
September 23, 2014
In November 2013, the U.S. Environmental Protection Agency (EPA) proposed waiving a substantial portion of the Renewable Fuel Standard (RFS) mandated volumes for 2014 and reducing the use of biofuels in U.S. transportation compared to 2013.1 The...
September 19, 2014
For nearly a decade, BIO has advocated actively for a nonproprietary naming convention that ensures all biological products are distinguishable. BIO believes that a distinguishable nonproprietary naming convention would best facilitate...
September 15, 2014
In general, we find the Draft Guidance imposes broad speaker based restrictions on manufacturer communications made via Internet and social media platforms associated with character-space and formatting limitations. As BIO has commented previously...
September 15, 2014
In general, the Draft Guidance provides comprehensive information about FDA’s proposed recommendations for companies seeking to correct misinformation on the Internet and social media platforms generated by independent third parties. There...
September 2, 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Sylvia M. Burwell Secretary Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Avenue, S.W. Washington, D.C. 20201   RE: Proposed...
September 2, 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence...
September 2, 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence...
September 2, 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence...
September 2, 2014
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 Current Good Manufacturing Practices—Interim Guidance for Human...
August 26, 2014
August 25, 2014 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: FDA Docket No. FDA-2014-D-0758-0001 Draft Guidance for Industry on Distributing Scientific and Medical...
August 12, 2014
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 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity...
August 8, 2014
June 30, 2014   BY ELECTRONIC DELIVERY   The Honorable Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G...
August 8, 2014
This Draft Guidance is related to the Drug Supply Chain Security Act (DSCSA), and is intended to aid trading partners in identifying a suspect product, to provide information on how to notify trading partners and FDA about illegitimate product,...
August 6, 2014
The Hon. Michelle K. Lee Deputy Under Secretary of Commerce Acting Director United States Patent and Trademark Office Via email to myriad-mayo_2014@uspto.gov Re: March 4, 2014, Guidance For Determining Subject Matter Eligibility Of Claims...