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Life Sciences › FDA Warning Letters

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

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The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Troutman Pepper Locke

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Troutman Pepper Locke

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

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The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Arnall Golden Gregory LLP

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

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“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2022

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Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

Don’t Go Changing . . . Unless You Ask FDA

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The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

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In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Hogan Lovells

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

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On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ and FDA Target Companies That Undermine FDA Oversight

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Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 2 of 3)

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Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

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The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

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• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

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In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

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Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

Hogan Lovells

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

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Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

Latham & Watkins LLP

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

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FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

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