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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies: Considerations for Study Design   Food and Drug Administration (FDA) Proposed
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CGO Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli  Food and Drug Administration (FDA) Proposed
Assessment of Pressor Effects of Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bispecific Antibody Development Programs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Brain Metastases  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part IX FDA References  Food and Drug Administration (FDA) Proposed
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry   Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
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