Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | Shudarsana Company
The U.S. Food and Drug Administration (FDA) has issued detailed guidance under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act)…
Read more →Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers
The U.S. Food and Drug Administration (FDA) recently released a guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on…
Read more →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…
Read more →Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act | Shudarsana Company
FDA Issues Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act In January 2025, the U.S. Food and…
Read more →Short Note on Regulation (EU) No 536/2014 on Clinical Trials
Regulation (EU) No 536/2014, enacted by the European Parliament and the Council on April 16, 2014, provides a comprehensive framework for the conduct of…
Read more →The EU Decentralised Clinical Trials Project: Revolutionizing Clinical Research
Background The landscape of clinical trials in the European Union (EU) is evolving, driven by the need for innovative trial designs and methodologies that…
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