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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 5th, 2008)
BIO’s comments to the FDA
Read the letter (57 KB PDF)
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
Read the letter (142 KB PDF)
Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices (March 17, 2008)
BIO's comments to the FDA
Read the letter (38 KB PDF)
Proposed Revised Annex 2: Manufacture of Biological Medicinal Products for Human Use (March 14, 2008)
BIO comments to the EMEA
Read the letter (153 KB PDF)
Jonca Bull, MD, Testifies on behalf of BIO to The Institute of Medicine Committee on Conflict of Interest in Medical Research, Education and Practice (March 13, 2008)
BIO's views on issues relating to conflict of interest in research.
Read the letter (686 KB PDF)
Joint BIO/PhRMA Comments on FDA's Draft 5-Year Information Technology Plan
(February 22, 2008)
BIO/PhRMA's comments to the FDA
Read the letter (122 KB PDF)
BIO's comments on "Maximizing the Public Health Benefit of Adverse Event Collection throughout a Product’s Marketed Lifecycle" (February 22, 2008)
BIO's comments to the FDA
Read the letter (57 KB PDF)
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule
(February 19, 2008)
BIO's comments to the FDA
Read the letter (181 KB PDF)
The World Medical Association reviews the Declaration on Helsinki (February 8, 2008)
BIO's comments to WMA regarding the
Declaration on Helsinki
Read the letter (1.6 MB PDF)
"FDA Science and Mission at Risk" (February 4, 2008)
BIO's comments to the FDA Science Board Subcommittee on Science and Technology
Read the letter (37 KB PDF)
The National Institute Occupational Saftey and Health (NIOSH) hazardous drugs list update (January 30, 2008)
BIO's comments to NIOSH
Read the letter (721 KB PDF)
Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation (January 14, 2008)
BIO's comments to the FDA
Read the letter (947 KB PDF)
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (December 17, 2007)
BIO's comments to the FDA
Read the letter (30 KB PDF)
International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System (October 11, 2007)
BIO's comments to the FDA
Read the letter (96 KB PDF)
Retroactive application of FDA Guidance (September 11, 2007)
BIO's White Paper to the FDA
Read the letter (153 KB PDF)
The World Medical Association reviews the Declaration on Helsinki (August 28, 2007)
BIO's comments to WMA regarding the Declaration on Helsinki
Read the letter (87 KB PDF)
Comments regarding In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) (August 27, 2007)
BIO's letter to the FDA
Read the letter (153 KB PDF)
Comments on EMEA's guideline for Human Cell-Based Medicinal Products (CBMP) (July 31, 2007)
BIO's comments to the European Medicines Agency
Read the comments (268 KB PDF)
Comments on EMEA's guidelines on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins (July 31, 2007)
BIO's comments to the European Medicines Agency
Read the comments (634 KB PDF)
Use of Medication Guides to Distribute Drug Risk Information to Patients (July 11, 2007)
BIO's comments to the FDA.
Read the comments (33 KB PDF)
Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees (May 29, 2007)
BIO's comments to the FDA
Read the comments (33 KB PDF)
EMEA's draft guideline "The Requirements for First-in-Human Clinical Trials for Potential High Risk Medicinal Products" (May 23, 2007)
BIO comments to the European Medicines Agency
Read the comments (151 KB PDF)
FDA Draft Guidance on International Conference on Harmonization: Terminology in Pharmacogenomics (April 9, 2007)
BIO Comments
Read the comments (22 KB PDF)
Comments on FDA's Sentinel Network to Promote Medical Product Safety (April 5, 2007)
Read the comments (41 KB PDF)
Comments on Proposed Rule on the Use of Materials Derived from Cattle (March 13, 2007)
Read the comments (31 KB PDF)
Public Availability of Labeling Changes (November 11, 2006)
BIO Comments on FDA's Draft Guidance
Read the comments (30 KB PDF)
Comments on Pharmacogenetic Tests and Genetic Tests for Heritable Markers (May 10, 2006)
Read the comments (57 KB PDF)
Comments on FDA's Labeling Guidance for Human Prescription Drug and Biological Products (April 24, 2006)
Warnings and Precautions, Contraindications, & Boxed Warning Sections (67 KB PDF)
Implementing the New Content and Format Requirements. (38 KB PDF)
BIO Comments on Investigational New Drugs
Approaches to Complying with Current Good Manufacturing Practice During Phase 1 (March 20, 2006)
Read the comments (47 KB PDF)
BIO Comments on Anti-Counterfeiting and Track-and-Trace Technologies
BIO statement before the FDA Anti-Counterfeit Drug Initiative Workshop and Vendor Display (February 8, 2006)
Read the statement (47 KB PDF)
Comments on Reporting and Reviewing Adverse Events
To the Office for Human Research Protections (January 13, 2006)
Read the comments (46 KB PDF)
BIO and 21 Patient Groups Issue Letter Supporting FDA's Critical Path Initiative (January 12, 2005)
Read the letter. (58 KB PDF)
Read the press release
Comments on Proposed Bulletin for Good Guidance Practices
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB). (January 9, 2005)
Read the comments (31 KB PDF)
Comments on the Revised Model Guidelines
To United States Pharmacopeia (Jan. 6, 2006)
Read the comments (46 KB PDF)
BIO Comments to Draft Guidance on Gene Therapy Clinical Trials; Long-term follow-up
Docket No. 2005D-0310 (Nov. 21, 2005)
Read the comments (28 KB PDF)
BIO Comments on Draft Guidance on the Pediatric Research Equity Act
Docket No. 2005D-0334 (Nov. 7, 2005)
Read the comments (107 KB PDF)
EMEAÃs draft guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance
Comments by BIO: EMEA/CHMP/42832/2005 (October 31, 2005)
Read the comments (113 KB PDF)
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 Colorectal Cancer System," and "Carotid Artery Stenting System"
Read the comments. (44 KB PDF)
International Clinical Trials Registry Platform (September 30, 2005)
Comments by BIO to the World Health Organization
Read the comments. (117 KB PDF)
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)
Read the comments. (203 KB PDF)
Proposed Changes to OPPS (September 16, 2005)
Comments by BIO; CMS-1501-P (Medicare Program; Proposed Changes to Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates) - NonPass-Throughs; Orphan Drugs; Vaccines; and Drug Administration
Read the comments. (66 KB PDF)
CMS's Competative Acquisition Program (September 6, 2005)
Comments by BIO; CMS-1325-IFC (Medicare Program; Competative Acquisition of Outpatient Drugs and Biologicals Under Part B)
Read the comments. (116 KB PDF)
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)
Read the comments. (90 KB PDF)
Exploratory Investigational New Drug (IND) Studies (July 13, 2005)
Comments by BIO; FDA Docket 2005D-0122
Read the comments. (32 KB PDF)
Comments on the draft ìGuideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance
Comments by BIO
Read the comments. (95 KB PDF)
Comments on Draft Guidance on Nonclinical Safety Evaluation of Drug Combinations. (April 26, 2005)
Docket No. 2005D-0004, Federal Register: January 26th, 2005 (Volume 70, Pages 3714-3715).
Read the comments. (29 KB PDF)
Comments on Docket No. 2005D-0022 , ìInternational Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals.î (April 11, 2005)
Comments by BIO
Read the comments. (25 KB PDF)
Comments on Docket No. 2004N-0355, Scientific considerations Related to Developing follow-on Protein Products (March 16, 2005)
Comments by BIO
Read the comments. (111 KB PDF)
EMEA's Draft Guideline on Similar Biological Medicinal Products (February 28, 2005)
Comments by BIO; CHMP/437/04
Read the comments. (111 KB PDF)
Comments on CMS's final rule with comment period regarding changes to the hospital outpatient prospective payment system (OPPS) and calendar year 2005 payment rates (January 14, 2005)
Federal Register CMS-1427-FC, November 15, 2004
Read the comments. (107 KB PDF)
Comments on Draft Guidance on Computerized Systems in Clinical Trials (January 5, 2005)
Docket No. 2004D-0440, Federal Register: October 4th, 2004 (Volume 69, Pages 59239-59240).
Read the comments. (283 KB PDF)
Comments on CMS's Revisions to Payment Policies Under Medicare Physician Fee Schedule (December 27, 2004)
CMS-1429-FC.
Read the comments. (146 KB PDF)
Comments on CMS's Draft Formulary Review Criteria (December 23, 2004)
as posted on CMS's Web site on December 3, 2004.
Read the comments. (188 KB PDF)
Comments on CMS's Draft Decision Memorandum for Anticancer Chemotherapy for Colorectal Cancer. (December 23, 2004)
CAG-00179N.
Read the comments. (116 KB PDF)
Scientific Considerations Related to Developing Follow-on Protein Products (December 13, 2004)
Docket No. 2004N-0355.
Read the comments. (424 KB PDF)
Comments on FDA's Draft Guidance for Industry on a Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practices Regulations (December 3, 2004)
Docket No. 2004D-0443, CDER 20041115.
Read the comments. (94 KB PDF)
Request for an extension of the comment period on the CMS draft coverage decision memorandum for anticancer chemotherapy for colorectal cancer (November 18, 2004)
CMS Draft Decision Memo CAG-00179N, November 1 2004
Read the comments. (52 KB PDF)
Comments to CMS' proposed rule regarding revisions to the hospital outpatient prospective payment system (HOPPS) (October 8, 2004)
Federal Register CMS-1427-P, August 16, 2004
Read the comments. (158 KB PDF)
Read CMS' response to BIO's comments. (115 KB PDF)
Comments on CMS' proposed rule regarding the Medicare Part D prescription drug benefit (October 4, 2004)
Federal Register CMS-4068-P, August 3, 2004.
Read the comments. (272 KB PDF)
Comments to CMS's proposed rule regarding revisions to payment policies (September 24, 2004)
Under the Medicare physician fee schedule.
Read the comments. (167 KB PDF)
Read CMS' response to BIO's comments. (101 KB PDF)
Comments on Medicare Prescription Drug Benefit Model Guidelines (September 17, 2004)
Comments to United States Pharmacopeia's draft Medicare Prescription Drug Benefit Model Guidelines.
Read BIO's comments. (144 KB PDF)
Comments on Proposed Rule on Human Subject Protection (September 8, 2004)
Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application: FDA Docket No. 2004N-0018.
Read BIO's comments.
Comments on Stimulating Innovation in Medical Technologies (August 23, 2004)
Docket No. 2004S-0233, Federal Register: May 24, 2004.
Read BIO's comments. (134 KB PDF)
Comments on Definition of PMOA of a Combination Product(August 20, 2004)
Docket No. 2004N-0194, Federal Register: May 7, 2004.
Read BIO's comments.
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")
Read BIO's comments. (36 KB PDF)
Comments on FDA Critical Path Initiative:
Docket No. 2004-N-0181, 69 Federal Register, 21839 (April 22, 2004)]. (August 2, 2004)
Read BIO's comments.
Comments regarding the Healthcare 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
Read BIO's comments. (112 KB PDF)
Comments to CMS' proposed rule regarding the Hospital Inpatient Prospective Payment System and Fiscal Year 2005 Rates. (July 12, 2004)
Federal Register CMS-1428-P, May 18, 2004
Read BIO's comments. (160 KB PDF)
Read CMS' response to BIO's comments. (105 KB PDF)
Suggestions for research priorities to AHRQ: (July 1, 2004)
In response to §1013 of the Medicare Prescription Drug, Improvement, and Modernization Act.
Read BIO's comments.
Comments to CMS' interim final rule regarding manufacturer submission of manufacturer's average saless price ("ASP") data for Medicare Part B drugs and Biologicals (June 7, 2004)
Federal Register CMS-1380-IFC, April 6, 2004
Read BIO's comments. (92 KB PDF)
Comments regarding ICH Q5E: (May 19, 2004)
Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process.
Read BIO's comments.
Comments regarding ICH E2E: (May 19, 2004)
Pharmacovigilance Planning (PvP).
Read BIO's comments.
Comments on Bioavailability and Bioequivalence Standards (May 11, 2004)
Read BIO's comments.
Comments regarding Help-Seeking and Other Disease Awareness Communications (May 10, 2004)
By or on Behalf of Drug and Device Firms. Read BIO's comments.
Statement Before The NIH Blue Ribbon Panel (May 16, 2004)
On Conflict of Interest Policies.
Read BIO's statement.
Comments regarding FDA's Draft Guidance for Industry (Apr. 5, 2004)
Providing Regulatory Submissions in Electronic Format ñ Content of Labeling.
Read BIO's comments.
Comments regarding Changes to an Approved NDA or Abbreviated NDA (Feb. 17, 2004)
Read BIO's comments.
Comments on Race and Ethnicity on MedWatch forms (Feb. 6, 2004)
Read BIO's comments. (121 KB PDF).
Comments regarding Pharmacogenomic Data Submissions (Feb. 2, 2004)
Read BIO's comments.
Comments on FDA's draft Guidance for Reviewers: (Dec. 5, 2003)
CMC for Human Somatic Cell Therapy INDs. Read BIO's comments (123 KB PDF).
Comments on FDA's draft Guidance for Industry: (Dec. 4, 2003)
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information.
Read BIO's comments (154 KB PDF).
Comments on FDA's Draft Guidance (Nov. 5, 2003)
For Process Analytical Technology.
Read BIO's comments.
Comments on FDA's Draft Guidance (Nov. 4, 2003)
For Sterile Drug Products Produced by Aseptic Processing.
Read BIO's comments.
Comments on FDA's Counterfeit Drug Task Force Interim Report
Read BIO's comments. (Nov. 3, 2003)
Comments on FDA's Draft Guidance
For Safety Reporting Requirements for Human Drug and Biological Products. Read BIO's comments. (Oct. 13, 2003)
Comments FDA's Draft Guidance (Mar. 28, 2003)
For Collection of Race and Ethnicity Data in Clinical Trials.
Read BIO's comments (4.9 MB PDF).
Comments regarding FDA's Guidance (June 17, 2003)
For Industry on Continuous Marketing Applications.
Read BIO's comments.
Comments regarding the U.S. Small Business Administration's Proposed Rule
To modify eligibility requirements for receiving SBIR funding.
Read BIO's comments and letters.
Comments on Draft OIG Compliance Guidance (Dec. 2, 2002)
For Pharmaceutical Manufacturers.
Read BIO's comments (13.5 MB PDF).
Statement on FDA Commissioner (Oct. 18, 2002)
Read BIO's statement.
Required Notification of Possession/Non-Possession of Select Agents Deadline (Aug. 8, 2002)
Public Health Security and Bioterrorism Response Act of 2002.
Read BIO's statement.
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