Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring drug safety and effectiveness. One of its key regulatory tools is the Risk Evaluation and Mitigation Strategies (REMS) program, which aims to manage known or potential serious risks associated with certain medications. The FDA’s guidance document, titled “Risk Evaluation and Mitigation Strategies: […]
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry
Introduction The U.S. Food and Drug Administration (FDA) has established guidelines for adverse event reporting (AER) concerning dietary supplements to ensure consumer safety and regulatory compliance. The document titled Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection […]
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 […]