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Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents: Draft…  Food and Drug Administration (FDA) Proposed
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry   Food and Drug Administration (FDA) Proposed
Rare Diseases: Natural History Studies for Drug Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommended Methods for Blood Grouping Reagents Evaluation: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Review and Update of Device Establishment Inspection Processes and Standards: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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