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Letters, Testimony & Comments

BIO Statement on Project BioShield II
October 6, 2004
HEARING ON PROJECT BIOSHIELD II OCTOBER 6, 2004 This statement is submitted by the Biotechnology Industry Organization (BIO), an organization representing over 1,000 companies, universities, research institutions, state biotechnology...
Comments on CMS' proposed rule regarding the Medicare Part D prescription drug benefit
October 4, 2004
Federal Register CMS-4068-P, August 3, 2004
BIO's Comments to FDA's Proposed Rule on Institutional Review Board (IRB) Registration Requirements
September 27, 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in...
Comments to Medicare physician fee schedule payment policies
September 24, 2004
Relating to CMS's proposed rule revisions
Comments to CMS's proposed rule regarding revisions to payment policies
September 24, 2004
Under the Medicare physician fee schedule.
Victory in Gilead Sciences Shareholder' Derivative Suit
September 20, 2004
On September 20, 2004, BIO submitted an amicus curiae brief in a California Court of Appeal supporting Gilead Sciences Inc's efforts to overturn a lower-court ruling in a shareholders' derivative action. Under California law, a...
Phillips v. AWH Corp., Hopeman Brothers Inc., and Lofton Corp
September 20, 2004
Comments on Medicare Prescription Drug Benefit Model Guidelines
September 17, 2004
Comments to United States Pharmacopeia's draft Medicare Prescription Drug Benefit Model Guidelines
Comments on Proposed Rule on Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
September 8, 2004
September 8th, 2004 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Docket No. 2004N-0018, Federal Register: June 10, 2004 (Volume 69, Number 112, Pages 32467-32475...
Response to Swedish Questionnaire
September 7, 2004
Dear Mr. Simon: I write on behalf of the Biotechnology Industry Organization (BIO) in response to your request for views of European industry on proposed requirements to indicate the origin of material in patent applications. BIO is a trade...
Testimony on 2005 OPPS Proposal and Other Medicare Issues
September 2, 2004
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify about the hospital outpatient department prospective payment system (OPPS) proposed rule for 2005. BIO is the largest trade organization to serve and represent...
Presentation Before the United States Pharmacopeia Medicare Prescription Drug Benefit Model Guidelines Public Meeting
August 27, 2004
Good morning, my name is Jayson Slotnik and I am here on behalf of the Biotechnology Industry Organization (BIO), the trade association for biotech companies, academic institutions and scientific entrepreneurs. Our over 1,000 members brought you...
Letter to the California Fish and Game Commission
August 25, 2004
RE: Comments regarding August 26, 2004 Meeting of California Fish and Game Commission, Agenda Item 3 Dear Mr. Kellogg: On behalf of BayBIO, BIOCOM, and the Biotechnology Industry Organization (BIO), we would like to express concern to the...
Letter to the California Fish and Game Commission
August 25, 2004
Expressing concern regarding the permitting system for the importation and possession of transgenic aquatic animals (August 25, 2004).
Comments on Stimulating Innovation in Medical Technologies
August 23, 2004
Docket No. 2004S-0233, Federal Register: May 24, 2004.
Comments on Definition of PMOA of a Combination Product
August 20, 2004
August 20th, 2004 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Docket No. 2004N-0194, Federal Register: May 7, 2004 (Volume 69, Number 89, Page 25527-25533) Dear Sir/...
Comments to the proposed changes to the Current Procedural Terminology ("CPT") codes related to the administration of drugs and biologicals
August 10, 2004
Joint letter with Plasma Protein Therapeutics Association (PPTA) concerning intravenous immune globulin ("IVIG")
Comments on FDA Critical Path Initiative
August 2, 2004
Docket No. 2004-N-0181, 69 Federal Register, 21839 (April 22, 2004)].
Comments regarding the Health Care Common Procedure Coding System ("HCPCS") coding process
July 26, 2004
Letter to Herb Kuhn, Director, Center for Medicare Management at the Centers for Medicare and Medicaid Services
Project BioShield Fact Sheet
July 24, 2004
Background: On February 3, 2003, President Bush unveiled the details of Project BioShield, a comprehensive effort by the federal government to stimulate drug and vaccine development, to protect American citizens against attacks by biological or...