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IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Informed Consent: Draft Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Proposed
The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Manufacturers, Retailers, Importers and FDA Staff  Food and Drug Administration (FDA) Proposed
Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol: Guidance for Reviewers  Food and Drug Administration (FDA) Final
Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs  Food and Drug Administration (FDA) Final
Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs   Food and Drug Administration (FDA) Final
Waiver of IRB Requirements for Drug and Biological Product Studies: Guidance For Sponsors, Clinical Investigators, and IRBs  Food and Drug Administration (FDA) Final
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions: Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food…  Food and Drug Administration (FDA) Final
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