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US FDA guidelines to conducting clinical trials

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FDA-USA : 

7/22/2009 1 FDA-USA Yugandhar k

FDA : 

7/22/2009 2 FDA The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.

FDA-Organizations : 

7/22/2009 3 FDA-Organizations The Office of the Commissioner (OC) The Center for Drug Evaluation and Research (CDER) The Center for Biologics Evaluation and Research (CBER) The Center for Food Safety and Applied Nutrition (CFSAN) The Center for Devices and Radiological Health (CDRH) The Center for Veterinary Medicine (CVM) The National Center for Toxicological Research (NCTR) The Office of Regulatory Affairs (ORA) The Office of Criminal Investigations (OCI)

FDA-Legal authoritys : 

7/22/2009 4 FDA-Legal authoritys 1902 – Biologics Control Act 1906 – Pure Food and Drug Act 1938 – Federal Food, Drug, and Cosmetic Act 1944 – Public Health Service Act 1951 – Food, Drug, and Cosmetics Act Amendments 1962 – Food, Drug, and Cosmetics Act Amendments 1966 – Fair Packaging and Labeling Act 1976 – Medical Device Regulation Act 1987 – Prescription Drug Marketing Act

FDA-Legal authoritys : 

7/22/2009 5 FDA-Legal authoritys 1988 – Anti–drug Abuse Act 1990 – Nutrition Labeling and Education Act 1992 – Prescription Drug User Fee Act 1994 – Dietary Supplement Health and Education Act 1997 – Food and Drug Modernization Act 2002 – Bioterrorism Act 2002 – Medical Device User Fee and Modernization Act (MDUFMA) 2003 – Animal Drug User Fee Act 2007 – Food and Drug Administration Amendments Act of 2007

FDA-Regulates : 

7/22/2009 6 FDA-Regulates The FDA regulates almost every face of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety FDA regulation of cosmetics is focused primarily on labeling and safety.

CFR Title 21 : 

7/22/2009 7 CFR Title 21 CFR Title 21 (Code Of Federal Regulation) - Food and Drugs: Parts 1 to 1499 different types of parts to food, drug , cosmetic and medical devices and etc For Conducting a clinical research on IND different imp parts is their

FDA Guidelines to conduct clinical trials : 

7/22/2009 8 FDA Guidelines to conduct clinical trials 21 CFR part 11- Electronic submission and Electronic signature 21 CFR part 50- Protection of human subjects 21 CFR part 54- Financial Disclosure by Clinical Investigators 21 CFR part 56- Institutional Review Board 21 CFR part 312- Investigational new drug application 21 CFR part 314- Application for FDA Approval to Market a New Drug

21 CFR part 11 : 

7/22/2009 9 21 CFR part 11 Part 11 covers: All aspects of electronic records, including signatures; integrity and authenticity; record creation; audit trails; and archiving Part 11 requires: Electronic records that are "created, modified, maintained, archived, retrieved, or transmitted, must be protected by procedures and controls to "ensure the authenticity, integrity and the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the document as not genuine."

21 CFR part 11 : 

7/22/2009 10 21 CFR part 11 Part 11 goals : To ensure electronic records and signatures are at least as authentic and traceable as those on paper.

21 CFR part 50 Human Subject Protection : 

7/22/2009 11 21 CFR part 50 Human Subject Protection subpart A - General Provisions subpart B - Informed Consent of Human Subjects subpart C - (Reserved) subpart D - Additional Safeguards for Children in Clinical Investigations

21 CFR part 50 Subpart A General Provisions : 

7/22/2009 12 21 CFR part 50 Subpart A General Provisions 50.1 - Scope. 50.3 - Definitions.

21 CFR part 50.3 Definitions. : 

7/22/2009 13 21 CFR part 50.3 Definitions. IRB ICF All definitions in content of ICF

21 CFR part 50 Subpart B Informed Consent of Human Subjects : 

7/22/2009 14 21 CFR part 50 Subpart B Informed Consent of Human Subjects 50.20 - General requirements for informed consent. 50.21 - Effective date. 50.23 - Exception from general requirements. 50.24 - Exception from informed consent requirements for emergency research 50.25 - Elements of informed consent. 50.27 - Documentation of informed consent.

21 CFR part 50.20 : 

7/22/2009 15 21 CFR part 50.20 General Requirements Legal & effective Opportunity to decide participation/ask questions Understandable language No exculpatory language No waiver of legal rights Privacy

21 CFR part 50.23 : 

7/22/2009 16 21 CFR part 50.23 Exception from general requirements

21 CFR part 50.24 : 

7/22/2009 17 21 CFR part 50.24 Exception from informed consent requirements for emergency research.

21 CFR part 50.25 : 

7/22/2009 18 21 CFR part 50.25 Elements Study involves research Purpose Duration Procedures Risks or discomforts to the subject Benefits Alternate procedures

21 CFR part 50.25 : 

7/22/2009 19 21 CFR part 50.25 Elements cont… Confidentiality statement Compensation Medical treatment Contact for questions and answers, rights emergencies Voluntary participation

21 CFR part 50.25 : 

7/22/2009 20 21 CFR part 50.25 Additional Elements Statement that the procedure may involve risks that are unforeseeable to subject, fetus Anticipated circumstances of withdraw Additional costs Consequences of early withdraw Significant new findings Number of study subjects No preemption of applicable state, local, federal law

21 CFR part 50.27 : 

7/22/2009 21 21 CFR part 50.27 Documentation Written consent approved by the IRB Signed by patient or legal representative Copy given to subject Contains all relevant elements

21 CFR 50 Subpart D Additional Safeguards for Children in Clinical Investigations : 

7/22/2009 22 21 CFR 50 Subpart D Additional Safeguards for Children in Clinical Investigations 50.50 - IRB duties. 50.51 - Clinical investigations not involving greater than minimal risk. 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects` disorder or condition. 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. 50.55 - Requirements for permission by parents or guardians and for assent by children. 50.56 - Wards.

21 CFR part 54 Financial Disclosure : 

7/22/2009 23 21 CFR part 54 Financial Disclosure 54.1 - Purpose. 54.2 - Definitions. 54.3 - Scope. 54.4 - Certification and disclosure requirements. 54.5 - Agency evaluation of financial interests. 54.6 - Record keeping and record retention.

21 CFR part 54- Financial Disclosure : 

7/22/2009 24 21 CFR part 54- Financial Disclosure FDA requires financial disclosure from Principal Investigators, Sub-investigators and their spouses and dependent children, if applicable. If you are listed on the 1572, you will be asked to complete a financial disclosure form at the beginning of the trial (and update the information as relevant, including one year following study completion).

Investigator/Site Responsibilities : 

7/22/2009 25 Investigator/Site Responsibilities FORM FDA 1572: Conduct the study in accordance with the protocol. Notify sponsor otherwise… Personally conduct or supervise the study. Explain the study and possible risks and benefits to subjects and obtain written informed consents prior to subjects’ participation in the study. Inform ALL staff participating in the conduct of the study of their responsibilities.

Investigator/Site Responsibilities : 

7/22/2009 26 Investigator/Site Responsibilities FORM FDA 1572 Cont’d Read and understand ALL relevant study information the protocol the investigator’s brochure, the package inserts Promptly report adverse events to the sponsor and the IRB. Maintain adequate and accurate records and make those available for inspection

Investigator/Site Responsibilities : 

7/22/2009 27 Investigator/Site Responsibilities FORM FDA 1572 Cont’d: Ensure that an IRB complies with the requirements including initial and continuing review and approval Report all changes in research and all unanticipated problems involving risks to the IRB. Will not implement changes in research without IRB approval, except where necessary to eliminate harm to subjects.

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21 CFR Part 56-Institutional Review Boards : 

7/22/2009 29 21 CFR Part 56-Institutional Review Boards Subpart A - General Provisions Subpart B - Organization and Personnel Subpart C - IRB Functions and Operations Subpart D - Records and Reports Subpart E - Administrative Actions for Noncompliance

21 CFR Part 56 Subpart A General Provisions : 

7/22/2009 30 21 CFR Part 56 Subpart A General Provisions 56.101 - Scope.  56.102 - Definitions.  56.103 - Circumstances in which IRB review is required.   56.104 - Exemptions from IRB requirement.   56.105 - Waiver of IRB requirement.

21 CFR Part 56 Subpart B Organization and Personnel : 

7/22/2009 31 21 CFR Part 56 Subpart B Organization and Personnel 56.107 - IRB membership.

21 CFR Part 56 Subpart C IRB Functions and Operations : 

7/22/2009 32 21 CFR Part 56 Subpart C IRB Functions and Operations 56.108 - IRB functions and operations.    56.109 - IRB review of research.    56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.    56.111 - Criteria for IRB approval of research.    56.112 - Review by institution.    56.113 - Suspension or termination of IRB approval of research.    56.114 - Cooperative research.

21 CFR Part 56 Subpart D Records and Reports : 

7/22/2009 33 21 CFR Part 56 Subpart D Records and Reports 56.115 - IRB records.

21 CFR Part 56 Subpart E Administrative Actions for Noncompliance : 

7/22/2009 34 21 CFR Part 56 Subpart E Administrative Actions for Noncompliance 56.120 - Lesser administrative actions.    56.121 - Disqualification of an IRB or an institution.    56.122 - Public disclosure of information regarding revocation.    56.123 - Reinstatement of an IRB or an institution.    56.124 - Actions alternative or additional to disqualification

21 CFR 312 Investigational new drug application : 

7/22/2009 35 21 CFR 312 Investigational new drug application Subpart A - General Provisions Subpart B - Investigations New Drug Application (IND) Subpart C - Administrative Actions Subpart D - Responsibilities of Sponsors and Investigators Subpart E - Drugs Intended to Treat Life Threatening and Severely Debilitating Illnesses Subpart F - Miscellaneous Subpart G - Drugs for Investigational Use in Laboratory Research Animals or in Vitro Tests

21 CFR 312 Subpart A General Provisions : 

7/22/2009 36 21 CFR 312 Subpart A General Provisions 312.1 - Scope.  312.2 - Applicability.  312.3 - Definitions and interpretations.  312.6 - Labeling of an investigational new drug.  312.7 - Promotion and charging for investigational drugs.  312.10 - Waivers.

21 CFR 312 Subpart BInvestigations New Drug Application (IND) : 

7/22/2009 37 21 CFR 312 Subpart BInvestigations New Drug Application (IND) 312.20 - Requirement for an IND. 312.21 - Phases of an investigation. 312.22 - General principles of the IND submission. 312.23 - IND content and format. 312.30 - Protocol amendments. 312.31 - Information amendments. 312.32 - IND safety reports. 312.33 - Annual reports. 312.34 - Treatment use of an investigational new drug. 312.35 - Submissions for treatment use. 312.36 - Emergency use of an investigational new drug. 312.38 - Withdrawal of an IND.

21 CFR 312 Subpart C Administrative Actions : 

7/22/2009 38 21 CFR 312 Subpart C Administrative Actions 312.40 - General requirements for use of an investigational new drug in a clinical investigation. 312.41 - Comment and advice on an IND. 312.42 - Clinical holds and requests for modification. 312.44 - Termination. 312.45 - Inactive status. 312.47 - Meetings. 312.48 - Dispute resolution.

21 CFR 312 Subpart D Responsibilities of Sponsors and Investigators : 

7/22/2009 39 21 CFR 312 Subpart D Responsibilities of Sponsors and Investigators 312.50 - General responsibilities of sponsors. 312.52 - Transfer of obligations to a contract research organization. 312.53 - Selecting investigators and monitors. 312.54 - Emergency research under Sec. 50.24 of this chapter. 312.55 - Informing investigators. 312.56 - Review of ongoing investigations. 312.57 - Recordkeeping and record retention. 312.58 - Inspection of sponsor`s records and reports. 312.59 - Disposition of unused supply of investigational drug.

21 CFR 312 Subpart D Responsibilities of Sponsors and Investigators : 

7/22/2009 40 21 CFR 312 Subpart D Responsibilities of Sponsors and Investigators 312.60 - General responsibilities of investigators. 312.61 - Control of the investigational drug. 312.62 - Investigator recordkeeping and record retention. 312.64 - Investigator reports. 312.66 - Assurance of IRB review. 312.68 - Inspection of investigator's records and reports. 312.69 - Handling of controlled substances. 312.70 - Disqualification of a clinical investigator.

21 CFR 312 Subpart E Drugs Intended to Treat Life Threatening and Severely Debilitating Illnesses : 

7/22/2009 41 21 CFR 312 Subpart E Drugs Intended to Treat Life Threatening and Severely Debilitating Illnesses 312.80 - Purpose. 312.81 - Scope. 312.82 - Early consultation. 312.83 - Treatment protocols. 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. 312.85 - Phase 4 studies. 312.86 - Focused FDA regulatory research. 312.87 - Active monitoring of conduct and evaluation of clinical trials. 312.88 - Safeguards for patient safety.

Section 312.87 Active Monitoring of Conduct and Evaluation of Clinical Trials : 

7/22/2009 42 Section 312.87 Active Monitoring of Conduct and Evaluation of Clinical Trials For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be involved in facilitating their appropriate progress.

Sec. 312.88 Safeguards for patient safety. : 

7/22/2009 43 Sec. 312.88 Safeguards for patient safety. All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing and the safety of products following marketing approval apply to drugs covered by this section. This includes the requirements for informed consent (part 50 of this chapter) and institutional review boards (part 56 of this chapter). These safeguards further include the review of animal studies prior to initial human testing (Sec. 312.23), and the monitoring of adverse drug experiences through the requirements of IND safety reports (Sec. 312.32), safety update reports during agency review of a marketing application (Sec. 314.50 of this chapter), and postmarketing adverse reaction reporting (Sec. 314.80 of this chapter).

21 CFR 312 Subpart F Miscellaneous : 

7/22/2009 44 21 CFR 312 Subpart F Miscellaneous 312.110 - Import and export requirements. 312.120 - Foreign clinical studies not conducted under an IND. 312.130 - Availability for public disclosure of data and information in an IND. 312.140 - Address for correspondence. 312.145 - Guidance documents.

21 CFR 312 Subpart G Drugs for Investigational Use in Laboratory Research Animals or in Vitro Tests : 

7/22/2009 45 21 CFR 312 Subpart G Drugs for Investigational Use in Laboratory Research Animals or in Vitro Tests 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

21 CFR part 314 : 

7/22/2009 46 21 CFR part 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

21 CFR part 314 Applications For FDA Approval To Market A New Drug : 

7/22/2009 47 21 CFR part 314 Applications For FDA Approval To Market A New Drug Subpart A - General Provisions Subpart B - Applications Subpart C - Abbreviated Applications Subpart D - FDA Action on Applications and Abbreviated Applications Subpart E - Hearing Procedures for New Drugs Subpart F - [Reserved] Subpart G - Miscellaneous Provisions Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

21 CFR part 314 Subpart A General Provisions : 

7/22/2009 48 21 CFR part 314 Subpart A General Provisions 314.1 - Scope of this part. 314.2 - Purpose. 314.3 - Definitions.

21 CFR part 314 Subpart B Applications : 

7/22/2009 49 21 CFR part 314 Subpart B Applications 314.50 - Content and format of an application. 314.52 - Notice of certification of invalidity or no infringement of a patent. 314.53 - Submission of patent information. 314.54 - Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug. 314.55 - Pediatric use information. 314.60 - Amendments to an unapproved application.

21 CFR part 314 Subpart B Applications : 

7/22/2009 50 21 CFR part 314 Subpart B Applications 314.65 - Withdrawal by the applicant of an unapproved application. 314.70 - Supplements and other changes to an approved application. 314.71 - Procedures for submission of a supplement to an approved application. 314.72 - Change in ownership of an application. 314.80 - Postmarketing reporting of adverse drug experiences. 314.81 - Other postmarketing reports. 314.90 - Waivers.

21 CFR part 314 Subpart C Abbreviated Applications : 

7/22/2009 51 21 CFR part 314 Subpart C Abbreviated Applications 314.92 - Drug products for which abbreviated applications may be submitted. 314.93 - Petition to request a change from a listed drug. 314.94 - Content and format of an abbreviated application. 314.95 - Notice of certification of invalidity or noninfringement of a patent.

21 CFR part 314 Subpart C Abbreviated Applications : 

7/22/2009 52 21 CFR part 314 Subpart C Abbreviated Applications 314.96 - Amendments to an unapproved abbreviated application. 314.97 - Supplements and other changes to an approved abbreviated application. 314.98 - Postmarketing reports. 314.99 - Other responsibilities of an applicant of an abbreviated application.

21 CFR part 314 Subpart D FDA Action on Applications and Abbreviated Applications : 

7/22/2009 53 21 CFR part 314 Subpart D FDA Action on Applications and Abbreviated Applications 314.100 - Timeframes for reviewing applications and abbreviated applications. 314.101 - Filing an application and receiving an abbreviated new drug application. 314.102 - Communications between FDA and applicants. 314.103 - Dispute resolution. 314.104 - Drugs with potential for abuse. 314.105 - Approval of an application and an abbreviated application. 314.106 - Foreign data.

21 CFR part 314 Subpart D FDA Action on Applications and Abbreviated Applications : 

7/22/2009 54 21 CFR part 314 Subpart D FDA Action on Applications and Abbreviated Applications 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act. 314.108 - New drug product exclusivity. 314.110 - Approvable letter to the applicant. 314.120 - Not approvable letter to the applicant. 314.122 - Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed

21 CFR part 314 Subpart D FDA Action on Applications and Abbreviated Applications : 

7/22/2009 55 21 CFR part 314 Subpart D FDA Action on Applications and Abbreviated Applications 314.125 - Refusal to approve an application. 314.126 - Adequate and well-controlled studies. 314.127 - Refusal to approve an abbreviated new drug application. 314.150 - Withdrawal of approval of an application or abbreviated application. 314.151 - Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act. 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.

21 CFR part 314 Subpart D - FDA Action on Applications and Abbreviated Applications : 

7/22/2009 56 21 CFR part 314 Subpart D - FDA Action on Applications and Abbreviated Applications 314.153 - Suspension of approval of an abbreviated new drug application. 314.160 - Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn. 314.161 - Determination of reasons for voluntary withdrawal of a listed drug. 314.162 - Removal of a drug product from the list. 314.170 - Adulteration and misbranding of an approved drug.

21 CFR part 314 Subpart E Hearing Procedures for New Drugs : 

7/22/2009 57 21 CFR part 314 Subpart E Hearing Procedures for New Drugs 314.200 - Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing. 314.201 - Procedure for hearings. 314.235 - Judicial review.

21 CFR part 314 Subpart G Miscellaneous Provisions : 

7/22/2009 58 21 CFR part 314 Subpart G Miscellaneous Provisions 314.410 - Imports and exports of new drugs. 314.420 - Drug master files. 314.430 - Availability for public disclosure of data and information in an application or abbreviated application. 314.440 - Addresses for applications and abbreviated applications. 314.445 - Guidance documents.

21 CFR part 314 Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses : 

7/22/2009 59 21 CFR part 314 Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses 314.500 - Scope. 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. 314.520 - Approval with restrictions to assure safe use. 314.530 - Withdrawal procedures. 314.540 - Postmarketing safety reporting. 314.550 - Promotional materials. 314.560 - Termination of requirements

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7/22/2009 60 thanks