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Audits Regulatory Requirements Food and Drug Administration (FDA)

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

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The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Gardner Law

State Licensing Requirements: Are You Prepared?

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Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more

Foley & Lardner LLP

Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and...

Foley & Lardner LLP on

Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on providing recommendations on...more

Gardner Law

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

Gardner Law on

When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Gardner Law

Beyond Paperwork: Assessing the Effectiveness of a Compliance Program

Gardner Law on

In the world of FDA-regulated companies, compliance with regulatory requirements is not just a matter of paperwork. It is a critical aspect that can significantly impact mergers and acquisitions (M&A) and the overall success...more

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