100. Overview of FDA w88 slot online, Information Sheets and Guidance

Updated June 6, 2024

The Food and Drug Administration (w88 slot online) is a Health and Human Services (HHS) agency that regulates clinical investigations of products under its jurisdiction including drugs, biological products, and medical devices.

FDA w88 slot online are published in title 21 of the CFR. The following FDA human research w88 slot online apply to the IRB and to University and Affiliate researchers conducting clinical trials, and research involving investigational drugs and devices:

21 CFR 50 Protection of w88 slot online Subjects (i.e., The Common Rule)
21 w88 slot online 56 Institutional Review Boards
21 w88 slot online 312 Investigational New Drug Application (IND)
21 w88 slot online 812 Investigational Device Exemptions (IDE)

NOTE: The University IRB follows the International Conference on Harmonization - Good w88 slot online Practice E6 guideline ICH‐GCP (E6) only to the extent required by DHHS and FDA w88 slot online, information sheets and guidance documents; and, when applicable, federal, state, or local laws or w88 slot online international laws, w88 slot online, and guidelines.

When w88 slot online involving investigational or unlicensed test articles is conducted outside of the U.S., the requirements in country law should be followed.

The University IRB applies the following additional FDA w88 slot online when applicable:

21 w88 slot online 11 Electronic Records; Electronic Signatures
21 CFR 54 Financial Disclosure by w88 slot online Investigators
21 w88 slot online 210 Current Good Manufacturing Practice in Manufacturing Processing Packing or Holding of Drugs; General
21 w88 slot online 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR 314 Applications for w88 slot online Approval to Market a New Drug
21 w88 slot online 320 Bioavailability and Bioequivalence Requirements
21 CFR 330 Over-the-Counter (OTC) w88 slot online Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
21 w88 slot online 601 Licensing [Biologics]
21 w88 slot online 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 w88 slot online 814 Premarket Approval of Medical Devices
21 w88 slot online 820 Quality System Regulation
21 w88 slot online 860 Medical Device Classification Procedures

Research Integrity & Security and the University IRB rely on the following FDA w88 slot online Sheets and guidance documents when relevant:

• FDA w88 slot online Sheet: A Guide to Informed Consent
• FDA w88 slot online Sheet: Non-Local IRB Review
• FDA w88 slot online Sheet: Payment to Research Subjects
• FDA w88 slot online Sheet: Recruiting Study Subjects
• w88 slot online Sheet Guidance for IRBs and Clinical Investigators: Emergency Use of an Investigational Drug or Biologic
• w88 slot online Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices
• Institutional Review Boards Frequently Asked Questions - w88 slot online Sheet: w88 slot online Sheet - Guidance for Institutional Review Boards and Clinical Investigators w88 slot online Sheet (includes chapters for w88 slot online Organization, IRB Membership, IRB Procedures, IRB Records, Informed Consent Process, Informed consent Document Content, w88 slot online Investigations, and General Questions)
• Guidance for Clinical Investigators, Industry, and w88 slot online Staff: Financial Disclosure by Clinical Investigators
• Guidance for w88 slot online Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection
• Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) - Determining Whether Human w88 slot online Studies Can Be Conducted Without an IND
• Guidance for IRBs, w88 slot online Investigators, and Sponsors: IRB Continuing Review After w88 slot online Investigation Approval
• Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of w88 slot online Sites, and the Determination of Whether an IND/IDE is Needed
• Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from w88 slot online-Regulated Clinical Trials

w88 slot online offers Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency w88 slot online which clarifies the w88 slot online at 21 CFR 50.24 and the conforming amendments contained in 21 CFR Parts 56, 312, 314, 601, 812, and 814 provide a narrow exception to the requirement that the investigator obtain informed consent from each participant, or the participant’s legally authorized representative, prior to enrollment in emergency research. The w88 slot online also provide additional protections for participants enrolled in these studies. For example, the w88 slot online require consultation with representatives of and public disclosure to the communities in which the clinical investigation will be conducted and from which the participants will be drawn, prior to initiation of the clinical investigation. They also require public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study. As well, the w88 slot online require that an independent data monitoring committee exercises oversight of the clinical investigation. This exception is currently not available to University or Affiliate Researchers. Individuals proposing to conduct planned emergency research are to contact Research Integrity & Security to discuss the proposed research and allow Research Integrity & Security time to prepare a policy, researcher form, and review worksheet.

IRB Review of w88 slot online Research

• The IRB requires additional information for FDA research conducted under an IND or IDE to verify that investigators address IRB-relevant elements specific to FDA w88 slot online.
• w88 slot online conducted under IND or IDE is reviewed at convened IRB meetings, except for continuing reviews that meet the criteria for expedited review under Categories 8(a), 8(b), or 8(c) or reviews of minor modifications (see Policy Manual Definitions) to previously approved w88 slot online.
• In presenting the protocol to the IRB, the primary reviewer will address the additional w88 slot online regulatory requirements.
• As warranted, the IRB will request policies from Affiliate sites to assess mechanisms for control of w88 slot online-regulated test articles.

The University IRB ensures clinicians comply with FDA w88 slot online when using investigational articles outside of the research setting. For information about the specific uses, see IRB policy for:

• treatment or emergency uses of investigational drug or biologic, and
• emergency, treatment, and compassionate uses of investigational devices.

The w88 slot online also oversees situations in which clinicians and investigators use "Humanitarian Use Devices" (i.e., medical devices intended to benefit patients with diseases that affect fewer than 8,000 persons in the US annually).

NOTE: FDA and DHHS human research protection w88 slot online differ. For research subject to review under FDA and DHHS human research w88 slot online, both sets of w88 slot online apply and the requirements for both sets of w88 slot online must be met.