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Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

Organization: FDA

Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry

Organization: FDA

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

Organization: FDA

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Organization: FDA

Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Organization: FDA

Clinical Pharmacology Considerations for Antibody-Drug Conjugates

Organization: FDA

Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases

Organization: FDA

Guideline on the Investigation of Drug Interactions

Organization: FDA

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Organization: FDA

COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products

Organization: FDA

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

Organization: FDA

Policy for Coronavirus Disease-2019 Tests During The Public Health Emergency (Revised)

Organization: FDA

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