India Proposes Classifying Manipulated Cells And Tissue Products As Drugs
Executive Summary
The Indian government is proposing to change the definition of a new drug to include substantially manipulated stem cell and tissue-based therapies.
You may also be interested in...
India’s Stem Cell Guidelines Mandate Additional Checks
Draft update to national guidelines factors in additional safeguards and makes it mandatory to establish institutional panels to review stem cell research. Gene editing would be an area of "restrictive" research.
Global Medtech Guidance Tracker: November 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape
The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.