Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products -2026/5/29

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application-2026/5/29

Statistical Approaches to Establishing Bioequivalence-2026/5/29

Content of Human Factors Information in Medical Device Marketing Submissions-2026/5/29

Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein-2026/5/21

Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations-2026/5/20

M11 Clinical Electronic Structured Harmonised Protocol-2026/5/20

Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework-2026/5/13

Development of Non-Opioid Analgesics for Acute Pain-2026/5/13

Development of Local Anesthetic Drug Products With Prolonged Duration of Effect-2026/5/13