Combination products are comprised of components that, individually, would
usually be regulated by separate Centers under different types of regulatory
authorities (i.e., biologics, devices, drugs). Each of the three review Centers
involved in the assessment of combination products, the Center for Biologics
Evaluation and Research (CBER), the Center for Drug Evaluation and Research
(CDER), and the Center for Devices and Radiological Health (CDRH), maintains
a comprehensive, regularly updated website that provides detailed information
describing their specific organizational structures, how to contact each of
the different Centers, and advice as to how applications should be prepared
for submission to the respective Centers.
A limited number of guidance documents refer directly to combination products.
As an aid to sponsors seeking to develop a combination product, the Office
of Combination Products (OCP) has compiled a listing of guidance documents
selected from those issued by CBER, CDER and CDRH that we believe would be
of interest to combination product sponsors. Some documents are general in
nature and assist sponsors in understanding the regulatory approaches of individual
FDA review Centers they may not frequently interact with, while others specifically
address combination products or cover a broad product class but address combination
product issues within the document. The documents compiled in this listing
are intended only to serve as a starting point for obtaining information on
the regulation of combination products. For complete, regularly updated, searchable
listings of all guidance documents issued by the respective review Centers,
please refer to their websites [(CBER): http://www.fda.gov/cber/guidelines.htm ;
(CDER): http://www.fda.gov/cder/guidance/index.htm ;
and (CDRH): http://www.fda.gov/cdrh/guidance.html ].
The list of documents maintained on the OCP website is organized by review
Center. OCP intends to update the listing as new guidance documents that may
be of interest to sponsors/manufacturers of combination products are developed
and issued.
Center for Devices and Radiological
Health (CDRH)
General Documents |
| Availability of Information
Given to Advisory Committee Members in Connection with CDRH Open Public
Panel Meetings; Draft Guidance for Industry and FDA Staff |
| CDRH Organizational Information |
| Convenience Kits Interim
Regulatory Guidance |
| Device Advice |
| Device Evaluation Information |
| Do it by Design- An Introduction to
Human Factors in Medical Devices |
| Draft Guidance for Industry: Container
and Closure Integrity Testing in Lieu of Sterility Testing as a Component
of the Stability Protocol for Sterile Products |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic
Format - General Considerations |
| FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect
on FDA Review Clock and Performance Assessment - Guidance for Industry
and FDA Staff |
| Federal Register: Natural Rubber-Containing
Medical Devices; User Labeling |
| Getting to Market with a Medical
Device |
| Guidance for Industry and FDA Staff: Premarket Approval Application Modular
Review |
| Guidance on Medical Device Patient
Labeling: Final Guidance for Industry and FDA Reviewers |
| Human Factors Points to Consider for
IDE Devices |
| Human Factors Principles for Medical Device
Labeling |
| Immunotoxicity Testing Guidance |
| Introductory Information Regarding CDRH
Guidance Documents |
| Least Burdensome: A Suggested Approach
to Resolving Least Burdensome Issues |
| Least Burdensome Provisions of
the FDA Modernization Act of 1997: Concept and Principles; Draft Guidance
for FDA and Industry |
| Least Burdensome: Suggested
Format for Developing and Responding to Deficiencies in Accordance with
the Least Burdensome Provisions of FDAMA |
| Medical Device Reporting |
| Medical Device Use-Safety: Incorporating
Human Factors Engineering into Risk Management |
| Office of Device Evaluation Blue Book Memos |
| Perspectives on Clinical Studies for Medical
Device Submissions (Statistical) |
| Pilot Program to Evaluate a
Proposed Globally Harmonized Alternative for Premarket Procedures - Guidance
for Industry and FDA |
| Premarket Approval Application Filing
Review - Guidance for Industry and FDA Staff |
| Quality System Information for
Certain Premarket Application Reviews: Guidance for Industry and FDA
Staff |
| Statistical Guidance for Clinical Trials
of Non-Diagnostic Medical Devices |
| User Fees: Assessing User Fees:
PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
Definitions, Bundling Multiple Devices in a Single Application, and Fees
for Combination Produces; Guidance for Industry and FDA |
Center for Devices and
Radiological Health (CDRH)
Division of Anesthesiology, General Hospital Infection Control and Dental
Devices |
| Dental Cements |
| Dental Composites |
| External Infusion Pumps |
| Guidance Document for Premarket Notification
Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer
and Nitrogen Dioxide Analyzer: Final |
| Implanted Infusion Ports |
| Reviewer Guidance for Nebulizers, Metered
Dose Inhalers, Spacers and Actuators |
| Intravascular Administration Sets |
| Pharmacy Compounding Systems |
| Short-Term and Long-Term Intravascular Catheters |
Divisions of Cardiovascular Devices |
| Draft Guidance for the Submission of Research
and Marketing Applications for Interventional Cardiology Devices: PTCA
Catheters, Atherectomy Catheters, Lasers, Intravascular Stents |
| Guidance for the Submission of Research
and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker
Lead Adaptor 510(k) Submissions |
| Human Heart Valve Allografts |
| Intravascular Brachytherapy |
| Vascular Graft Prostheses |
Division of General, Restorative,
and Neurological Devices |
| Absorbable Hemostatic Device |
| Class II Special Controls Guidance
Document:Resorbable Calcium Salt Bone Void Filler Device;Guidance for
Industry and FDA - Guidance forIndustry and FDA Staff |
| Draft Guidance for the Preparation of IDE
Submissions for Interactive Wound and Burn Dressing |
| Guidance Document for Dura Substitute
Devices; Final Guidance for Industry |
| Guidance Document for the Preparation of IDEs
for Spinal Systems |
| Guidance for the Preparation of a Premarket
Notification Application for Processed Human Dura Mater; Final |
| Guidance for Resorbable Adhesion
Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance
for Industry |
| Medical Devices Containing Materials Derived
from Animal Sources (Except for In Vitro Diagnostic Devices) |
Division
of Ophthalmic and Ear, Nose and Throat Devices |
| Tympanostomy Tubes, Submission Guidance
for a 510(k) Premarket Notification; Final |
Division
of Reproductive, Abdominal and Radiological Devices |
| Class II Special Controls Guidance
Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture
Processing Applications; Final Guidance for Industry and FDA |
| Devices used for In Vitro Fertilization
and Related Assisted Reproduction Procedures: Draft |
| Draft Guidance for Preclinical and
Clinical Investigations of Urethral Bulking Agents Used in the Treatment
of Urinary Incontinence |
| Draft Guidance to Firms on Biliary Lithotripsy
Studies |
| Guidance for the Content of Premarket
Notifications for Conventional and Antimicrobial Foley Catheters |
| Guidance for the Submission of PreMarket
Notifications for Emission Computed Tomography Devices and Accessories
(SPECT and PET) and Nuclear Tomography Systems; FINAL |
| Guidance for the Submission of PreMarket
Notifications for Magnetic Resonance Diagnostic Devices; FINAL |
| Harmonic Imaging with/without Contrast-
Premarket Notification; FINAL |
| Information for a Latex Condom 510(k)
Submission for Obstetrics-Gynecology Devices Branch- Draft |
| Information for Condoms with a Spermicidal
Lubricant 510(k) Submission for Obstetrics-Gynecology Devices Branch |
| Latex Condoms for Men-Information for
510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated
Submissions |
| Testing Guidance for Male Condoms made
from New Material (Non-Latex) |
| Uniform Contraceptive Labeling; Final |
| 510(k) Checklist for Sterile Lubricating
Jelly used with Transurethral Surgical Instruments |
Center
for Devices and Radiological Health (CDRH)
Office of Compliance |
| Medical Device Tracking - Guidance
for Industry and FDA Staff |
| Sterilized Convenience Kits for
Clinical and Surgical Use; Final Guidance for Industry |
Office
of In Vitro Diagnostic Device Evaluation and Safety |
| Class II Special Controls Guidance
Document: Cyclosporine and Tacrolimus Assays; Draft Guidance for Industry
and FDA |
| Document for Special Controls for Erythropoietin
Assay Premarket Notifications [510(k)s]; Final |
| DRAFT Guidance for Industry/FDA
Reviewers: Multiplex Tests for Heritable DNA Markers, Mutations and Expression
Patterns |
| Draft Guidance for Industry: Pharmacogenomic Data Submissions |
| Guidance Criteria for Cyclosporine PMAs |
| Guidance on Review Criteria for Assessment
of Antimicrobial Susceptibility Devices; Draft |
| In Vitro Diagnostic Fibrin Monomer Paracoagulation
Test; Final |
| Premarket Approval Applications
for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV):
Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection,
Hepatitis C, or Other HCV-Associated Disease; Draft Guidance for Industry
and FDA |
| Review Criteria for Assessment of Antimicrobial
Susceptibility Test Discs |
Center
for Drug Evaluation and Research (CDER)
CDER General Guidance Documents
|
| CDER Manual of Policies and Procedures |
| CDER: Who We Are and What We Do |
| Changes to an Approved NDA or ANDA Questions
and Answers |
| Classifying Resubmissions in Response
to Action Letters |
| Clinical Studies Section of Labeling
for Prescription Drugs and Biologics-- Content and Format |
| Comprehensive List of CDER Guidance Documents |
| Content and Format of the Adverse
Reactions Section of Labeling for Human Prescription Drugs and Biologics |
| Content and Format of Investigational
New Drug Applications (INDs) for Phase 1 Studies of Drugs |
| Continuous Marketing Applications:
Pilot 1 – Reviewable Units for Fast Track Products Under PDUFA,
DRAFT Guidance |
| Continuous Marketing Applications:
Pilot 2 - Scientific Feedback and Interactions During Development of
Fast Track Products Under PDUFA, DRAFT Guidance |
| Disclosure of Materials Provided
to Advisory Committees in Connection with Open Advisory Committee Meetings
Convened by the Center for Drug Evaluation and Research Beginning on
January 1, 2000 |
| Draft Guidance for Industry: Pharmacogenomic Data Submissions |
| Draft Guidance for Industry: Submitting
Separate Marketing Applications and Clinical Data for Purposes of Assessing
User Fees |
| Drug Approval Application
Process |
| Exploratory IND
Studies |
| Fees-Exceed-the-Costs Waivers Under
the Prescription Drug User Fee Act |
| Formal Meetings With Sponsors and
Applicants for PDUFA Products: Guidance for Industry |
| Format and Content of the Clinical
and Statistical Sections of an Application |
| Format and Content of the Summary
for New Drug and Antibiotic Applications |
| Formatting, Assembling and Submitting
New Drug and Antibiotic Applications |
| Frequently Asked Questions on
Drug Development and Investigational New Drug Applications |
| Good Review Management
Principles and Practices for PDUFA Products |
| IND Meetings for Human Drugs and
Biologics Chemistry, Manufacturing, and Controls Information |
| Information Request and Discipline
Review Letters Under the Prescription Drug User Fee Act |
| Investigational
New Drug Application Process |
| New Drug Application
Process |
| Postmarketing Safety Reporting for
Human Drug and Biological Products Including Vaccines |
| Postmarketing Reporting of Adverse
Drug Experiences |
| Preparation of Investigational
New Drug Products (Human and Animal) |
| Submitting and Reviewing Complete
Responses to Clinical Holds |
Biological Therapeutic Products |
| Biological Therapeutic Products |
| Inspections of Licensed Biological Therapeutic Drug Products |
| |
| Bioanalytical Method Validation |
Chemistry,
Manufacturing and Controls (CMC) |
| BACPAC I: Intermediates in Drug
Substance Synthesis; Bulk Actives Post-Approval Changes: Chemistry, Manufacturing,
and Controls Documentation |
| Bioanalytical Method Validation |
| Changes to an Approved Application
for Specified Biotechnology and Specified Synthetic Biological Products |
| Changes to an Approved NDA or ANDA |
| Chemistry, Manufacturing and Controls
Information, Drug Product |
| Container Closure Systems for Packaging
Human Drugs and Biologics Questions
and Answers |
| Content and Format of Investigational
New Drug Applications (INDs) for Phase 1 Studies of Drugs |
| Demonstration of Comparability of
Human Biological Products, Including Therapeutic Biotechnology-derived
Products |
| Drug Master Files |
| Drug Product: Chemistry, Manufacturing,
and Controls Information |
| Drug Substance: Chemistry, Manufacturing, and Controls Information |
| Environmental Assessment of Human
Drug and Biologics Applications |
| INDs for Phase 2 and Phase 3 Studies:
Chemistry, Manufacturing and Controls Information |
| Liposome Drug Products: Human Pharmacokinetics
and Bioavailability; and Labeling Documentation- Draft Guidance |
| Metered Dose Inhaler (MDI) and Dry
Powder Inhaler (DPI) Drug Products |
| Monoclonal Antibodies Used as Reagents
in Drug Manufacturing |
| Nasal Spray and Inhalation Solution,
Suspension, and Drug Products |
| Sourcing
and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine
Spongiform Encephalopathy (BSE) |
| Reviewer Guidance, Validation of Chromatographic
Methods |
| Submission Documentation for Sterilization
Process Validation in Applications for Human and Veterinary Drug Products |
| Submitting Documentation for the
Manufacturing of and Controls for Drug Products |
| Submitting Documentation for the
Stability of Human Drugs and Biologics |
| Submitting Samples and Analytical
Data for Methods Validation |
| Validation of the Limulus Amebocyte
Lysate Test as an End-Product Endotoxin Test for Drugs, Biologics and
Medical Devices |
| |
| Cancer Drug and Biological Products
- Clinical Data in Marketing Applications |
| Chronic Cutaneous Ulcers and Burn
Wounds- Developing Products for Treatment |
| Clinical Development Programs for
MDI and DPI Drug Products |
| Clinical Development Programs for
Drugs, Devices, and Biological Products Intended for the Treatment of
Osteoarthritis |
| Clinical Development Programs for
Drugs, Devices, and Biological Products for the Treatment of Rheumatoid
Arthritis |
| Clinical Trial
Endpoints for the Approval of Cancer Drugs and Biologics |
| Collection of Race and Ethnicity
Data in Clinical Trials |
| Content of Investigational New Drug
Applications for Phase I Studies of Drugs Including Well Characterized,
Therapeutic, Biotechnology-derived Products |
| Developing Medical Imaging Drugs
and Biological Products: Part 1 (Conducting Safety Assessments) |
| Developing Medical Imaging Drugs
and Biological Products: Part 2 (Clinical Indications) |
| Developing Medical Imaging Drugs
and Biological Products: Part 3 (Design, Analysis and Interpretation
of Clinical Studies) |
| Drugs, Biologics and Devices Derived
from Bioengineered Plants for Use in Humans and Animals |
| General Considerations for the
Clinical Evaluation of Drugs |
| General Considerations for the
Clinical Evaluation of Drugs in Infants and Children |
| Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed
Drug or Biological Products for the Treatment of Cancer |
| Institutional Review
Boards, Clinical Investigators, and Sponsors: Exception from Informed
Consent Requirements for Emergency Research |
| Integration of Dose-Counting Mechanisms
into MDI Drug Products |
| Providing Clinical Evidence of Effectiveness
for Human Drug and Biological Products |
| |
| Estimating the Safe Starting Dose
in Clinical Trials for Therapeutics in Adult Healthy Volunteers |
| Format and Content of the Human
Pharmacokinetics and Bioavailability Section of an Application |
| General Considerations for Pediatric
Pharmacokinetic Studies for Drugs and Biological Products |
| Pharmacokinetics
in Patients with Impaired HepaticFunction: Study Design, Data Analysis,
and Impact on Dosing and Labeling |
| |
| CDER Pre-Approval Inspections/Investigations |
| General Principles of Process Validation |
| Good Laboratory Practice Regulations
Questions and Answers |
| Inspections of Licensed Biological Therapeutic Drug Products |
| Sterile Drug Process Inspections |
| Sterile Drug Products Produced
by Aseptic Processing |
| |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic
Format - General Considerations |
| Example of an Electronic New
Drug Application Submission |
| Part 11, Electronic Records; Electronic
Signatures -- Scope and Application |
| Providing Regulatory Submissions
in Electronic Format — ANDAs |
| Providing Regulatory Submissions
in Electronic Format - Postmarketing Expedited Safety Reports |
| Providing Regulatory Submissions
in Electronic Format: Postmarketing Periodic Adverse Drug Experience
Reports- DRAFT Guidance for Industry |
| Providing Regulatory Submissions
in Electronic Format - Prescription Drug Advertising and Promotional
Labeling |
| Regulatory Submissions in Electronic
Format; General Considerations |
| Regulatory Submissions in Electronic
Format; New Drug Applications |
| |
| Format and Content of the Microbiology
Section of an Application |
| |
| Content and Format of INDs for Phase
1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived
Products |
| Format and Content of the Nonclinical
Pharmacology/Toxicology Section of an Application |
| Nonclinical Safety Evaluation of Drug or Biologic Combinations |
| |
| Current Good Manufacturing Practice Regulations |
| International Conference on Harmonization
Refer to |
| Modernization Act of 1997: FDAMA Refer
to |
Center
for Biologics Evaluation and Research (CBER)
CBER General Guidance Documents |
| CBER 101: An Introduction to the
Center for Biologics Evaluation and Research -Multiple Presentations |
| CBER 101: An Introduction
to the Center for Biologics Evaluation and Research- Useful Websites |
| CBER Organizational Information |
| Changes to an Approved Application:
Biological Products |
| Changes to an Approved Application
for Specified Biotechnology and Specified Synthetic Biological Products |
| Classifying Resubmissions in Response
to Action Letters |
| Clinical Studies Section of Labeling
for Prescription Drugs and Biologics-- Content and Format |
| Content and Format of the Adverse
Reactions Section of Labeling for Human Prescription Drugs and Biologics |
| Continuous Marketing Applications:
Pilot 1 - Reviewable Units for Fast Track Products Under PDUFA, DRAFT
Guidance |
| Continuous Marketing Applications:
Pilot 2 - Scientific Feedback and Interactions During Development of
Fast Track Products Under PDUFA, DRAFT Guidance |
| Disclosing Information Provided
to Advisory Committees in Connection with Open Advisory Committee Meetings
Related to the Testing or Approval of Biologic Products and Convened
by the Center for Biologics Evaluation and Research |
| Draft Guidance for Industry: Pharmacogenomic Data Submissions |
| Draft Guidance for Industry: Submitting
Separate Marketing Applications and Clinical Data for Purposes of Assessing
User Fees |
| FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect
on FDA Review Clock and Performance Assessment - Guidance for Industry
and FDA Staff |
| Fees-Exceed-the-Costs Waivers Under
the Prescription Drug User Fee Act |
| Formal Meetings With Sponsors and Applicants
for PDUFA Products: Guidance for Industry |
| Frequently Asked Questions |
| Good Review Management Principles and Practices for PDUFA Products |
| Guidance for Industry and FDA Staff: Premarket Approval Application Modular
Review |
| Guidance for Industry: Independent
Consultants for Biotechnology Clinical Trial Protocols |
| IND Meetings for Human Drugs and
Biologics Chemistry, Manufacturing, and Controls Information |
| Information on Submitting an IND for a Biological
Product |
| Information Request and Discipline
Review Letters Under the Prescription Drug User Fee Act |
| Manual of Regulatory Standard Operating
Procedures and Policies |
| Postmarketing Safety Reporting
for Human Drug and Biological Products Including Vaccines |
| Submitting and Reviewing Complete
Responses to Clinical Holds: Guidance for Industry |
| |
| Changes to an Approved Application:
Biological Products: Human Blood and Blood Components Intended for Transfusion
or for Further Manufacture |
| Efficacy Studies to Support Marketing
of Fibrin Sealant Products Manufactured for Commercial Use |
| Premarket Notifications [510(k)s]
for In Vitro HIV Drug Resistance Genotype Assays: Special Controls |
| |
| Draft Guidance for Reviewers:
Instructions and Template for Chemistry, Manufacturing, and Control (CMC)
Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications
(INDs) |
| Guidance for Human Somatic Cell Therapy
and Gene Therapy |
| Supplemental Guidance on Testing
for Replication Competent Retrovirus in Retroviral Vector Based Gene
Therapy Products and During Follow-up of Patients in Clinical Trials
Using Retroviral Vectors |
Chemistry,
Manufacturing and Control |
| Analytical Procedures and Methods Validation
- Chemistry, Manufacturing, and Controls Documentation |
| Container Closure Systems for Packaging
Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation |
| Draft Guidance for Reviewers:
Instructions and Template for Chemistry, Manufacturing, and Control (CMC)
Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications
(INDs) |
| Drug Substance: Chemistry, Manufacturing, and Controls Information |
| Environmental Assessment of Human Drug
and Biologics Applications |
| Guidance For the Submission of Chemistry,
Manufacturing and Controls Information and Establishment Description
for Autologous Somatic Cell Therapy Products |
| Points to Consider in the Characterization
of Cell Lines Used to Produce Biologicals |
| Submission of Chemistry, Manufacturing
and Controls and Establishment Description Information for Human Plasma-Derived
Biological Products, Animal Plasma or Serum-Derived Products |
| Submission of Chemistry, Manufacturing,
and Controls Information for a Therapeutic Recombinant DNA-Derived Product
or a Monoclonal Antibody Product for In Vivo Use: Guidance for Industry |
| |
| Clinical Studies Section of Labeling
for Prescription Drugs and Biologics--Content and Format: Draft Guidance
for Industry |
| Clinical Trial Endpoints for the
Approval of Cancer Drugs and Biologics |
| Content and Format of the Adverse
Reactions Section of Labeling for Human Prescription Drugs and Biologics:
Draft Guidance for Industry |
| Estimating the Safe Starting Dose
in Clinical Trials for Therapeutics in Adult Healthy Volunteers |
| Guidance for Industry: IND Exemptions for Studies of Lawfully
Marketed Drug or Biological Products for the Treatment of Cancer |
| Pharmacokinetics
in Patients with Impaired HepaticFunction: Study Design, Data Analysis,
and Impact on Dosing and Labeling |
| |
| FDA Modernization Act of 1997; List
of Documents Issued by the FDA That Apply to Medical Devices Regulated
by CBER |
| |
| Manufacture and Testing of Monoclonal
Antibody Products for Human Use |
| Points to Consider in the Manufacture
and Testing of Therapeutic Products for Human Use Derived from Transgenic
Animals |
| Supplement to the Points to Consider
in the Production and Testing of New Drugs and Biologics Produced by
Recombinant DNA Technology: Nucleic Acid Characterization and Genetic
Stability |
| |
| Availability of Licensed Donor Screening
Tests Labeled for Use with Cadaveric Blood Specimens: Guidance for Industry |
| Draft Guidance for Industry: Preventive
Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
| FEDERAL REGISTER Current Good Tissue
Practice for Manufacturers of Human Cellular and Tissue-Based Products;
Inspection and Enforcement; Proposed Rule |
| FEDERAL REGISTER Human Cells,
Tissues, and Cellular and Tissue-Based Products; Establishment Registration
and Listing; Final Rule |
| FEDERAL REGISTER Human Tissue Intended
for Transplantation; Final Rule |
| FEDERAL REGISTER Suitability Determination
for Donors of Human Cellular and Tissue-Based Products; Proposed Rule |
| Guidance on Applications for Products
Comprised of Living Autologous Cells Manipulated ex vivo and Intended
for Structural Repair or Reconstruction |
| Proposed Approach to Regulation
of Cellular and Tissue-Based Products |
| Screening and Testing of Donors of
Human Tissue Intended for Transplantation: Guidance for Industry |
| Validation of Procedures for Processing
of Human Tissues Intended for Transplantation: Guidance for Industry |
| |
| Guidance for Industry: Source Animal,
Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation
Products in Humans |
| PHS Guideline on Infectious Disease
Issues in Xenotransplantation |
| Precautionary Measures to Reduce
the Possible Risk of Transmission of Zoonoses by Blood and Blood Products
from Xenotransplantation Product Recipients and Their Intimate Contacts |
| |
| Electronic Submissions |
| International Conference on Harmonization |
| Providing Regulatory Submissions
in Electronic Format: Postmarketing Periodic Adverse Drug Experience
Reports- DRAFT Guidance for Industry |
