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 […]
Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | Shudarsana Company
Introduction In January 2025, the U.S. Food and Drug Administration (FDA) released crucial guidance titled “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” This guidance addresses significant health risks linked to HCT/Ps, including outbreaks of Mycobacterium tuberculosis (Mtb) infections caused […]
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children | Shudarsana Company
FDA Guidance on Lead in Processed Baby and Toddler Food: Key Highlights and Impact The U.S. Food and Drug Administration (FDA) has issued a comprehensive Guidance for Industry to establish action levels for lead in processed food intended for babies and young children. This guidance is part of the FDA’s Closer to Zero initiative, which […]
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment guidance provides recommendations to sponsors regarding the development of drugs and biological products regulated by CDER and CBER for the adjuvant treatment of renal cell carcinoma. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of […]
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative […]