For pharmaceutical and biotech companies, FDA compliance is not just a regulatory obligation—it is essential for ensuring patient safety,...
How Medical Device Companies Can Avoid FDA Inspection Findings – And the Consequences of Noncompliance
For medical device companies, compliance with FDA regulations is not just a legal obligation—it is critical to ensuring patient safety, product...
Donor Eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): FDA’s Evolving Guidance
The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety of Human Cells, Tissues, and Cellular and Tissue-Based...
FDA’s Perspective on AI in Drug and Biological Product Development
Artificial Intelligence (AI) is rapidly transforming the pharmaceutical and biotechnology industries, offering powerful tools to accelerate drug...
Navigating the Future: FDA’s Draft Guidance on AI-Enabled Medical Device Software
Artificial Intelligence (AI) is revolutionizing healthcare, particularly in the medical device sector. AI-powered software is now integrated into...
Navigating Regulatory Shifts: How RFK Jr.’s Policies Could Impact Medical Device and Pharmaceutical Approvals
Robert F. Kennedy Jr.'s potential influence on the U.S. healthcare regulatory environment could bring significant changes to the approval and...
FDA Issues Draft Guidance on the Accelerated Approval of Drugs and Biologics
The FDA has released a draft guidance, Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics, outlining proposed...