Home

Letters, Testimony & Comments

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 27 2013
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 19 2013
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
February 4 2013
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
IRB: BIO Comments on Draft Guidance for IRBs
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
Unique Device Identification System Comments
  Re:Docket No. FDA-2011-N-0090: Proposed Rule: Unique Device Identification System Dear Sir/Madam: The Biotechnology Industry...
November 7 2012
Biosimilar Patent Certification: University Associations Ask FDA to Not Undermine Their Patent Rights
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised...
November 5 2012
PDUFA V: BIO Comments on FDA's NME Review Program Assessment
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
August 5 2012
Accelerated Approval: BIO Comments on pCR in Neoadjuvant Treatment for Breast Cancer
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
July 29 2012
REMS: BIO Comments on Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
July 6 2012
Clinical Trials: BIO Submits Comments on FDA's Modernizing the Regulation of Clinical Trials
Dear Sir/Madam: BIO thanks the FDA for the opportunity to provide comments on Modernizing the Regulation of Clinical Trials and...
May 30 2012
DDI: BIO Comments on FDA's Draft Guidance for Industry Drug Interaction Studies
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA)...
May 20 2012
Biosimilars: BIO Comments on FDA's Biosimilars User Fee Cover Sheet
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 13 2012
FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
May 11 2012
Risk Evaluation: BIO Comments on ICH's Proposed Guideline on E2C(R2) Periodic Benefit-Risk Evaluation Report
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 10 2012
Drug Safety: BIO Comments on FDA's Communication to the Public
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 7 2012
Drug Safety: BIO Comments on FDA's Draft Guidance on Classifying Significant Postmarket Drug Safety Issues
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 7 2012
Biosimilars: BIO Comments on Questions and Answers Regarding Implementation of BPCIA
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
Biosimilars: BIO Comments on Quality Considerations
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
Biosimilars: BIO Comments on Scientific Considerations
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
Safety Labeling: Establishing Timeframes for Implementation of Product Safety Labeling Changes
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
February 21 2012
Biosimilar User Fees: BIO Testifies at Biosimilar User Fee Public Hearing
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee...
December 16 2011
Transparency Initiative:Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
December 2 2011
Risk-Based Monitoring: BIO Comments on Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
November 28 2011
PDUFA V: BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
  On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment on the reauthorization of the...
October 24 2011
Mobile Medical Applications: BIO Comments
Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications...
October 19 2011
CDER Science & Research Needs: BIO Comments on CDER Draft Report
  Re: Docket No. FDA-2011-D-0239: Identifying the Center for Drug Evaluation and Research’s Science and Research Needs...
September 26 2011
Sterility Testing: BIO's Comments on Amendments to Sterility Test Requirements for Biological Products
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
September 19 2011
BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only
September 1, 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
September 1 2011
ICH Q11: BIO Comments on International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances
September 1, 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
September 1 2011
Nanotechnology: BIO's Comments on Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
August 15, 2011
Re: Docket No. FDA-2010-D-0530:  Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves...
August 15 2011
Animal Biotechnology: Letter in Support of a Science-Based Review Process at FDA
August 2, 2011
Dear Senators Reid and McConnell and Representatives Boehner and Pelosi: We are deeply concerned about recent action in the U.S. House...
August 2 2011
BIO Supports the Pandemic and All-Hazards Preparedness (PAHPA) Reauthorization Act of 2011
July 25, 2011
The Honorable Michael J. Rogers 133 Cannon HOB U.S. House of Representatives Washington, DC 20515 Dear Representative Rogers: On...
July 25 2011
BIO Submits Comments on Financial Disclosure by Clinical Investigators Guidance
July 25, 2011
BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain relationships. It is important to...
July 25 2011
BIO Comments Following FDA Public Meeting: Ultra High Throughput Sequencing for Clinical Diagnostic Applications
July 23, 2011
BIO commends the FDA for prospectively seeking input from industry to ensure that the regulatory environment is supportive of the rapid...
July 23 2011
Testimony before House Energy and Commerce Subcommittee on Health
July 7, 2011
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-...
July 7 2011
BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA)
June 9, 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
BIO Comments on the FDA's Draft Guidance for the Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies
April 19, 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
April 19 2011
BIO Submits Comments on FDA’s Good Laboratory Practice for Nonclinical Laboratory Studies
February 22, 2011
Re: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies Dear Sir/Madam: The...
February 22 2011
BIO Submits Comments on FDA’s Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
February 14, 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational...
February 14 2011
BIO Comments on FDA’s Draft Guidance for Industry on Qualification Process for Drug Development Tools
January 24, 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools;...
January 24 2011
BIO Submits Comments on FDA’s Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters
January 11, 2011
Re: Docket No. FDA-2010-D-0319 Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters:...
January 11 2011
BIO Comments on Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies
December 28, 2010
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 2010
BIO Comments on the Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable Biological Products
December 23, 2010
Re: Docket No. FDA-2010-N-0477, Request for Comments on the Food and Drug Administration Approval Pathway for Biosimilar and...
December 23 2010
Parallel Review of Medical Products
December 16, 2010
Re: Parallel Review of Medical Products [FDA-2010-N-0308] Dear Dr. Berwick and Dr. Hamburg: The Biotechnology Industry Organization (...
December 16 2010
Food Labeling; Labeling of Food Made From AquAdvantage Salmon
November 19, 2010
Re: (Docket No. FDA-2010-N-0385) Food Labeling; Labeling of Food Made From AquAdvantage Salmon Dear Sir/Madam: The Biotechnology...
November 19 2010
Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials
November 8, 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials...
November 8 2010
FDA: Strategic Priorities for Fiscal Year 2011-2015
November 1, 2010
Re: Docket No. Docket No. FDA-2010-N-0506, Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic...
November 1 2010
FDA Guidance Document: Transdermal Drug Delivery Systems
November 1, 2010
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir...
November 1 2010
BIO's comments to the FDA supporting the goals of the Draft Guidance to reduce the potential for suicidal behavior, ideation and attempts during drug treatment.
October 29, 2010
Re: Docket No. FDA–2010–N–0437, Development and Distribution of Patient Medication Information for Prescription Drugs...
October 29 2010
FDA: Chemistry, Manufacturing, and Controls (CMC) Reporting
September 23, 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
Genetically Engineered Salmon: FDA, VMAC Advisory Committee Meeting
September 20, 2010
Members of the Veterinary Medical Advisory Committee, My name is Dr. David Edwards, and I am the Director of Animal Biotechnology for...
September 20 2010
FDA: Investigational New Drug Applications; Co-Development of Investigational New Drugs
September 7, 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug...
September 7 2010
FDA: Oversight of Laboratory Developed Tests (LDT)
August 15, 2010
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO...
August 15 2010
FDA: Transparency Initiative
July 20, 2010
BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees...
July 20 2010
Reauthorization of the Prescription Drug User Fee Act (PDUFA)
April 12, 2010
On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment in support of the reauthorization of the...
April 12 2010
Assay Development for Immunogenicity Testing of Therapeutic Proteins
February 2, 2010
February 2 2010
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
November 18, 2009
November 18 2009
Food and Drug Administration Transparency Task Force, Public Meeting
November 6, 2009
November 6 2009
Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submission
September 28, 2009
September 28 2009
Food and Drug Administration Transparency Task Force
August 5, 2009
August 5 2009
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
July 27, 2009
Re: Docket No. FDA-2009-D-0179, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological...
July 27 2009
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
June 1, 2009
Re: Docket No. FDA- 2009-D-0095. Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products –...
June 1 2009
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
April 16, 2009
Re: Docket No. FDA-2009-D-0001, OC 2008299   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the...
April 16 2009
Draft Guidance, Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
April 16, 2009
Re: Docket No. FDA-2008-D-0659. Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues...
April 16 2009
The Draft Guidance for Industry on Good Importer Practices
April 13, 2009
Re: Docket No. FDA-2009-D-0675, OC 20091. Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
April 13 2009
BIO Comments to NIH on Expansion of the Clinical Trial Registry and Results Data Bank
April 13, 2009
Re: Docket No. NIH-2009-0002: Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank Introduction BIO...
April 13 2009
Sentinel Initiative: Structure, Function, and Scope
March 27, 2009
Re: Docket No. FDA-2008-N-0612, OC 2008312. Sentinel Initiative: Structure, Function, and Scope; Public Workshop   Dear Sir/...
March 27 2009
Draft Guidance, Animal Models-Essential Elements to Address Efficacy Under the Animal Rule
March 23, 2009
Re: Docket No. FDA- 2009-D-2007. Animal Models - Essential Elements to Address Efficacy Under the Animal Rule Dear Sir/Madam: The...
March 23 2009
FDA Draft Guidance on Potency Tests for Cellular and Gene Therapy Products
January 6, 2009
BIO comments to the FDA
January 6 2009
FDA Draft Guidance on End-of-Phase 2A (EOP2A) Meetings
November 25, 2008
Re: Docket No. FDA-2008-D-0514: End-of-Phase 2A Meetings Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the...
November 25 2008
International Conference on Harmonisation; Draft Guidance on E2F Development Safety Update Report (DSUR)
November 3, 2008
Re: Docket No. FDA-2008-D-0386: International Conference on Harmonisation; Draft Guidance on E2F Development Safety Update Report;...
November 3 2008
"Computerised Systems", Annex 11 to the EU’s GMP Guide
October 31, 2008
Re: Draft Annex 11 “Computerised Systems” Dear Sir/Madam, The Biotechnology Industry Organization (BIO) appreciates the...
October 31 2008
Section 102 Certification Requirements of the Consumer Product Safety Improvement Act of 2008
October 31, 2008
Re: Section 102 Certificate Requirements Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Consumer Product...
October 31 2008
FDA Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings
October 6, 2008
Re: Docket No. FDA-2008-D-0417: Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings; Availability...
October 6 2008
Whether Form FDA 3674 should accompany all clinical submissions to an Investigational New Drug (IND) file
September 26, 2008
Re: OMB control number 0910-0616, Docket No. FDA-2008-N-0144, Agency Information Collection Activities; Submission for Office of...
September 26 2008
Expansion of the ClinicalTrials.gov Database
September 8, 2008
Re: BIO Comments Regarding Expansion of the ClinicalTrials.gov Database Dear Dr. Zarin and Dr. Morton: The Biotechnology Industry...
September 8 2008
Requirements for Pregnancy and Lactation Labeling
August 27, 2008
Re: FDA Docket 2006N-0467: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy...
August 27 2008
Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets
June 6, 2008
Re: Docket No. FDA–2008N–0234: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies...
June 6 2008
New certification requirement under Sec. 402(j) of the Public Health Service (PHS) Act, including on the proposed certification form to accompany drug, biological product, and device applications
May 5, 2008
May 5 2008
Reprint Practices for the Distribution of Medical Journal Articles et al. on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
April 21, 2008
BIO's comments to the FDA
April 21 2008
Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
March 17, 2008
March 17 2008
Proposed Revised Annex 2: Manufacture of Biological Medicinal Products for Human Use
March 14, 2008
March 14 2008
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule
February 19, 2008
February 19 2008
"FDA Science and Mission at Risk"
February 4, 2008
February 4 2008
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
December 17, 2007
December 17 2007
International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System
October 17, 2007
BIO's comments to the FDA (96 KB PDF)
October 17 2007
Retroactive application of FDA Guidance
September 11, 2007
September 11 2007
Comments regarding In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)
August 27, 2007
Re: Docket No. 2006D-0347, Federal Register: July 26, 2007 (Volume 72, Pages 41081- 41083) Dear Sir/Madam, The following comments...
August 27 2007
Use of Medication Guides to Distribute Drug Risk Information to Patients
July 11, 2007
Re: Docket No. 2007N–0121: Use of Medication Guides to Distribute Drug Risk Information to Patients Dear Sir or Madam: The...
July 11 2007
Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
May 29, 2007
May 29 2007
Testimony before the House Committee on Energy and Commerce, Health Subcommittee
April 17, 2007
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today...
April 17 2007
FDA Draft Guidance on International Conference on Harmonization: Terminology in Pharmacogenomics
April 9, 2007
April 9 2007
Comments on FDA's Sentinel Network to Promote Medical Product Safety
April 5, 2007
April 5 2007
Comments on Proposed Rule on the Use of Materials Derived from Cattle
March 13, 2007
March 13 2007
Statement by BIO at FDA Public Meeting
February 16, 2007
The Biotechnology Industry Organization (BIO) welcomes this opportunity to comment on the success of the Prescription Drug User Fee Act (...
February 16 2007
Public Availability of Labeling Changes
November 11, 2006
November 11 2006
Comments on Pharmacogenetic Tests and Genetic Tests for Heritable Markers
May 10, 2006
May 10 2006
Comments on FDA's Labeling Guidance for Human Prescription Drug and Biological Products
April 24, 2006
April 24 2006
BIO Comments on Investigational New Drugs
March 20, 2006
March 20 2006
BIO Comments on Anti-Counterfeiting and Track-and-Trace Technologies
February 8, 2006
February 8 2006
Comments on Reporting and Reviewing Adverse Events
January 13, 2006
January 13 2006
BIO Comments to Draft Guidance on Gene Therapy Clinical Trials; Long-term follow-up
November 21, 2005
November 21 2005
Statement by BIO at FDA Public Meeting
November 14, 2005
November 14 2005
BIO Comments on Draft Guidance on the Pediatric Research Equity Act
November 5, 2005
November 5 2005
EMEAA's draft guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance
October 31, 2005
October 31 2005
Comments on Systems of Records
October 28, 2005
Notices of new systems of records: "Data Collection Secondary to Coverage Decision System," "Anti-Cancer Chemotherapy for...
October 28 2005
Revisions to Payment Policies Under the Physician Fee Schedule
September 30, 2005
Comments by BIO; CMS-1502-P (Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006)
September 30 2005
FDA's "Drug Watch" for Emerging Drug Safety Information
August 8, 2005
Comments by BIO; FDA Draft guidance; Docket 0062, Federal Register: May 10, 2005 (Volume 70, No. 89)
August 8 2005
Exploratory Investigational New Drug (IND) Studies
July 13, 2005
Comments by BIO; FDA Docket 2005D-0122
July 13 2005
Comments on the draft Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance
June 17, 2005
June 17 2005
Comments on Docket No. 2005D-0022 , International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
April 11, 2005
April 11 2005
Comments on FDA Draft Guidance on Using a Centralized IRB Process
March 27, 2005
The Biotechnology Industry Organization (“BIO”) is pleased to have the opportunity to comment on the Food and Drug...
March 27 2005
Comments on Docket No. 2004N-0355, Scientific considerations Related to Developing follow-on Protein Products
March 16, 2005
March 16 2005
BIO and 21 Patient Groups Issue Letter Supporting FDA's Critical Path Initiative
January 12, 2005
January 12 2005
Comments on Proposed Bulletin for Good Guidance Practices
January 9, 2005
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB).
January 9 2005
Comments on FDA Critical Path Initiative
August 2, 2004
Docket No. 2004-N-0181, 69 Federal Register, 21839 (April 22, 2004)].
August 2 2004
BIO Comments on Disease Awareness
May 10, 2004
May 10, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland...
May 10 2004
Comments regarding FDA's Draft Guidance for Industry
April 5, 2004
Providing Regulatory Submissions in Electronic Format ñ Content of Labeling.
April 5 2004
Comments regarding Changes to an Approved NDA or Abbreviated NDA
February 17, 2004
February 17, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
February 17 2004
Comments on FDA's draft Guidance for Reviewers
December 5, 2003
CMC for Human Somatic Cell Therapy INDs
December 5 2003
Comments on FDA's draft Guidance for Industry
December 4, 2003
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information.
December 4 2003
Comments on FDA's Draft Guidance
November 5, 2003
November 5, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
November 5 2003
Comments on FDA's Draft Guidance For Sterile Drug Products Produced by Aseptic Processing
November 5, 2003
November 4, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
November 5 2003
Comments on FDA's Counterfeit Drug Task Force Interim Report
November 3, 2003
November 3rd, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
November 3 2003
BIO Comments on FDA's Proposed Rule for Safety Reporting Requirements
October 13, 2003
October 13, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
October 13 2003
BIO Letter of Support for H.R. 2857, the Pediatric Research Equity Act of 2003
September 17, 2003
The Honorable James Greenwood 2436 Rayburn House Office Building U.S. House of Representatives Washington, DC 20515 The Honorable...
September 17 2003
BIO's Comments regarding FDA's draft guidance
July 28, 2003
On Good Review Management Principles.
July 28 2003
Comments regarding FDA's Guidance For Industry on Continuous Marketing Applications
June 17, 2003
Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No...
June 17 2003
Comments FDA's Draft Guidance For Collection of Race and Ethnicity Data in Clinical Trials
March 28, 2003
March 28 2003
Reauthorization of the Prescription Drug User Fee Act
March 6, 2002
Mr. Chairman and Members of the Subcommittee, I am Mary K. Pendergast, Executive Vice President for Government Affairs at Elan...
March 6 2002

Letters, Testimony & Comments

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
IRB: BIO Comments on Draft Guidance for IRBs
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
More Letters, Testimony & Comments →

Press Releases

Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations
February 1 2012
Washington, D.C. (February 1, 2012) – Richard Pops, Chairman and CEO of Alkermes plc, testified today on behalf...
BIO Statement on “Food Labeling” Petition to FDA
October 4 2011
Washington, D.C. (October 4, 2011) – A coalition of anti-technology groups under the moniker “Just Label...
BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
September 1 2011
Washington, D.C. (September 1, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
Hill Leadership: Support Science-Based Assessments by FDA
August 3 2011
Washington, D.C. (August 3, 2011) – In a letter to Congressional Leadership, the Biotechnology Industry...
More Press Releases →