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Article | June 04, 2024

Medtech Maturity: Assessing Regulatory Readiness

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Article | May 30, 2024

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

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Article | May 22, 2024

New Q-Submission Guidance: Key Insights and Tips

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Article | May 20, 2024

Chevron Challenges: Supreme Court Decisions Could Reshape FDA Authority

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Article | May 16, 2024

FDA Issues Draft Guidance on Informed Consent for Sponsors, Investigators, and Institutional Review Boards

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Article | May 14, 2024

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

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Article | May 09, 2024

FDA Issues Reminder for Medical Device Manufacturers to Ensure Data Reliability

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Article | May 07, 2024

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

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Article | April 25, 2024

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

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Article | April 23, 2024

Senators Urge FDA: Fix Ad Oversight

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Article | April 16, 2024

Amidst Legal Fight, HHS Revises Online Tracking Guidance

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Article | April 09, 2024

What Manufacturers Need to Know About PFAS

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Article | April 04, 2024

FDA Issues Supplemental Draft Guidance for Premarket Cybersecurity

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Article | April 02, 2024

FDA's View on Cannabis

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Article | March 27, 2024

Record Year for the DOJ: FCA Enforcement Trends

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Article | March 21, 2024

FDA Finalizes New QMSR for Medical Device Manufacturers

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Article | March 18, 2024

FDA Untitled Letter Targets Misleading Drug Advertising

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Article | March 14, 2024

Nevada Filing Deadlines are Approaching: What Manufacturers Need to Know

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Article | March 12, 2024

FDA Issues Numerous Warning Letters

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Article | March 06, 2024

CCPA Regulations to Take Effect Immediately

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Article | March 04, 2024

Highlights from OIG’s New Compliance Program Guidance

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Article | February 29, 2024

New Jersey Passes Comprehensive Consumer Privacy Law

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Article | February 21, 2024

FDA’s CDER Issues FY2023 Annual Report

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Article | February 13, 2024

What does FDA think of AI?

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