Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring that new drugs and biological products meet safety, efficacy, and quality…
Read more →Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
In August 2024, the U.S. Food and Drug Administration (FDA) released the final guidance document titled “Optimizing the Dosage of Human Prescription Drugs and…
Read more →M12 Drug Interaction Studies
In August 2024, the U.S. Food and Drug Administration (FDA) released the M12 Drug Interaction Studies Guidance for Industry, developed in collaboration with the…
Read more →FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
In August 2024, the U.S. Food and Drug Administration (FDA) released the “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety…
Read more →CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
The U.S. Food and Drug Administration (FDA) has released the updated Guidance for Industry #100, titled “Impurities: Residual Solvents in New Veterinary Medicinal Products,…
Read more →Providing Over-the-Counter Monograph Submissions in Electronic Format
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. One of its key…
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