FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
The U.S. Food and Drug Administration (FDA) provides detailed guidance on the nonclinical studies required to support Investigational New Drug (IND) applications. The document, “Nonclinical Safety Evaluation of Drug or Biologic Combinations,” outlines key recommendations for conducting preclinical studies that ensure the safety of investigational products before they proceed to human trials. This article highlights […]
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide
The U.S. Food and Drug Administration (FDA) continues to modernize regulatory processes by encouraging electronic submissions for Investigational New Drug (IND) applications. The FDA’s guidance document, “Electronic Submissions for IND Applications,” provides essential recommendations on transitioning from paper-based to electronic submissions, ensuring compliance with regulatory standards and improving efficiency. This article highlights key takeaways from […]
CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
The U.S. Food and Drug Administration (FDA) plays a critical role in overseeing the safety and efficacy of investigational drugs before they enter clinical trials. The FDA’s guidance document, “Investigational New Drug (IND) Applications,” provides essential recommendations for submitting IND applications, ensuring compliance with regulatory standards. This article highlights key takeaways from the guidance and […]
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
The U.S. Food and Drug Administration (FDA) continues to evolve its regulatory framework to incorporate advancements in digital health technologies (DHTs). The FDA’s guidance document, “Digital Health Technologies for Drug Development,” provides crucial recommendations for the use of digital tools in clinical trials and regulatory submissions. This article highlights key takeaways from the guidance and […]
Bioresearch Monitoring Technical Conformance Guide
The U.S. Food and Drug Administration (FDA) plays a pivotal role in establishing regulatory standards for drug development and approval. The FDA’s guidance document, “Clinical Trial Endpoints for Drug Development,” provides essential recommendations for selecting appropriate endpoints in clinical trials. This article highlights key takeaways from the guidance and its implications for pharmaceutical companies, researchers, […]
Control of Nitrosamine Impurities in Human Drugs
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring that the pharmaceutical supply chain remains resilient and that drug shortages are minimized. The FDA’s guidance document, “Manufacturing, Supply Chain, and Drug Shortages,” provides essential recommendations for drug manufacturers to maintain product availability and manage disruptions effectively. This article highlights key takeaways […]
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 standards before they reach the market. The FDA’s guidance document, “Benefit-Risk Assessment for New Drug and Biologic Approvals,” provides a structured framework for evaluating the benefits and risks associated with these […]
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 Biological Products for the Treatment of Oncologic Diseases.” This guidance aims to assist sponsors in identifying optimized dosages for oncology drugs and biological products during clinical development, prior to submitting approval […]
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 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guidance aims to harmonize approaches in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical […]