Article | June 04, 2024

Medtech Maturity: Assessing Regulatory Readiness

Read More
Article | May 30, 2024

FDA Publishes Paper Identifying Focus Areas for “Responsible Use of AI” in Medical Products

Read More
Article | May 22, 2024

New Q-Submission Guidance: Key Insights and Tips

Read More
Article | May 20, 2024

Chevron Challenges: Supreme Court Decisions Could Reshape FDA Authority

Read More
Article | May 16, 2024

FDA Issues Draft Guidance on Informed Consent for Sponsors, Investigators, and Institutional Review Boards

Read More
Article | May 14, 2024

CMS Audits on the Horizon: Prepare for Increased CMS Audits Under the Sunshine Act

Read More
Article | May 09, 2024

FDA Issues Reminder for Medical Device Manufacturers to Ensure Data Reliability

Read More
Article | May 07, 2024

From Discretion to Regulation: FDA's New Path for LDTs

Read More
Article | April 25, 2024

Using Personal Data to Train AI? Make Sure You Comply with State Requirements

Read More
Article | April 23, 2024

Senators Urge FDA: Fix Ad Oversight

Read More
Article | April 16, 2024

Amidst Legal Fight, HHS Revises Online Tracking Guidance

Read More
Article | April 09, 2024

What Manufacturers Need to Know About PFAS

Read More