Gardner Law

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including… more

Compliance, Drug Pricing, FDA Approval, Fees, Food and Drug Administration (FDA)

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Mark Gardner

[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA

Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain… more

Acquisitions, Continuing Legal Education, Cybersecurity, Data Breach, Department of Justice (DOJ)

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David Graham

FDA Signals Interest in Defining Ultraprocessed Foods

In June 2025, the U.S. Food and Drug Administration announced it is evaluating whether to formally define the term ultraprocessed food (UPF)—a move that could influence future labeling regulations, public health guidance, and… more

Consumer Protection Laws, Food and Drug Administration (FDA), Food Labeling, Food Safety, Manufacturers

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Amanda Johnston

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the product… more

Best Practices, Compliance, Enforcement Actions, Food and Drug Administration (FDA), Manufacturers

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Darya Lucas

Staying Prepared Amid FDA Changes

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the FDA… more

Compliance, Enforcement Actions, Food and Drug Administration (FDA), Manufacturers, Medical Devices

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Tim Philips

FDA’s Proposed Compliance “Revamp”: What Does It Mean for the Agency, Industry, and Consumers?

FDA Human Foods Program (HFP) Proposal Update - In a news release dated June 27, 2023, the Food & Drug Administration provided an update on its proposal to create a unified Human Foods Program (HFP), which includes a new… more

Compliance, Food and Drug Administration (FDA), Unions

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Paul Rothermel

Why Every Manufacturer Needs a Robust Information Security Program

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators… more

Cyber Insurance, Cybersecurity, Data Privacy, Data Protection, Food and Drug Administration (FDA)

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Brynn Stanley

FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs

Lastly, there are several clinical factors the Agency encourages sponsors to consider. One way psychedelics differ from other drugs is that the use of a traditional placebo as a control may be challenging, as an active drug… more

Clinical Trials, Controlled Substances Act, DEA, Draft Guidance, Food and Drug Administration (FDA)

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Gardner Law

Nathan Downing

The Value of MDUFA

Mark Gardner

[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA

David Graham

FDA Signals Interest in Defining Ultraprocessed Foods

Amanda Johnston

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Darya Lucas

Staying Prepared Amid FDA Changes

Tim Philips

FDA’s Proposed Compliance “Revamp”: What Does It Mean for the Agency, Industry, and Consumers?

Paul Rothermel

Why Every Manufacturer Needs a Robust Information Security Program

Brynn Stanley

FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs

Gardner Law

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