Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
The U.S. Food and Drug Administration (FDA) has issued a comprehensive guidance document titled Adaptive Designs for Clinical Trials of Drugs and Biologics. This document serves as a roadmap for pharmaceutical companies, clinical researchers, and regulatory professionals, outlining best practices for incorporating adaptive design methodologies in clinical trials. What is an Adaptive Design? Adaptive design […]
Drug Product Tracing: The Effect of Section 585 of the FD&C Act
The U.S. Food and Drug Administration (FDA) has issued comprehensive guidelines on the mandatory reporting of serious adverse events associated with dietary supplements. This guidance, outlined in the document titled Guidance for Industry: Questions and Answers Regarding the Mandatory Reporting of Adverse Events for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug […]
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act
The U.S. Food and Drug Administration (FDA) has provided comprehensive guidance on postmarketing safety reporting (PMSR) requirements for combination products. This document, titled Postmarketing Safety Reporting for Combination Products, outlines the necessary steps and regulatory expectations for manufacturers, applicants, and other stakeholders to ensure compliance with FDA regulations. Scope of the Guidance Combination products, which […]
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
Introduction The U.S. Food and Drug Administration (FDA) provides regulatory guidance to ensure the development and evaluation of safe and effective drugs and biologics. One such guidance document, titled “Adaptive Designs for Clinical Trials of Drugs and Biologics,” offers essential recommendations on designing flexible and efficient clinical trials. Adaptive designs allow for modifications to ongoing […]
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment
Introduction Navigating the regulatory landscape of drug and biologic approvals in the United States requires clear communication between sponsors and the U.S. Food and Drug Administration (FDA). The FDA’s guidance document, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” provides a structured approach to engaging with the agency during the development […]
Conducting Clinical Trials With Decentralized Elements
Conducting Clinical Trials With Decentralized Elements Introduction The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the quality, safety, and compliance of drugs and biologics through inspections and assessments. To enhance regulatory oversight and improve efficiency, the FDA has issued guidance on Remote Regulatory Assessments (RRAs). This approach allows the FDA […]
Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products | Shudarsana Company
The U.S. Food and Drug Administration (FDA) has introduced new regulatory requirements for cosmetic product manufacturers under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). These updates aim to enhance safety, transparency, and compliance within the cosmetic industry. If you manufacture, distribute, or sell cosmetic products in the U.S., understanding these changes is crucial […]
Global Unique Device Identification Database (GUDID) | Shudarsana Company
The U.S. Food and Drug Administration (FDA) has outlined specific requirements for medical device manufacturers regarding adverse event reporting under the Medical Device Reporting (MDR) regulations. This guidance, available in detail in the document “Medical Device Reporting for Manufacturers” (FDA, March 2022 update), aims to ensure timely identification and mitigation of potential risks associated with […]
Institutional Review Board (IRB) Written Procedures | Shudarsana Company
FDA Issues New Guidance on IRB Written Procedures: Key Insights for Institutions The U.S. Food and Drug Administration (FDA) has released updated guidance on Institutional Review Board (IRB) Written Procedures in February 2025 to align with evolving human subject research regulations. This new guidance reflects the FDA’s commitment to harmonizing regulations with the Department of […]