Michael Purcell
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Articles by Michael Purcell
Drug Labeling, Software, and the First Amendment: FDA Finalizes Guidance on Prescription Drug Use-Related Software While Defending Its Authority
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Drug Labeling, Software, and the First Amendment: FDA Finalizes Guidance on Prescription Drug Use-Related Software While Defending Its Authority
We've updated our Privacy Statement. Before you continue, please read our new Privacy Statement and familiarize yourself with the terms.
CLEAR Investigate: Ushering in the era of agentic AI for corporate risk & fraud professionals
The investigative landscape is shifting faster than ever. Data is multiplying, risks are coalescing in real time, and compliance expectations aren’t easing up for anyone. Criminals are using more sophisticated methods—from synthetic identities to AI-generated misinformation—making it harder than ever to separate real risk from noise. For professionals on the front lines, the job has become a constant race against volume, velocity, and complexity.
Why data quality is critical
← Blog home On July 2, 2025, the Office of the Comptroller and the Currency (OCC), along with the Federal Deposit Insurance Corporation (FDIC) and the National Credit Union Administration (NCUA), issued a pivotal exemption to the Customer Identification Program (CIP) Rule. This change allows financial institutions to use third-party sources to obtain a customer’s Taxpayer Identification Number (TIN) including Social Security Numbers (SSN) —instead of collecting it directly from the customer.
Regulation of Laboratory Developed Tests in APAC | JD Supra
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical diagnosis, and generally developed in response to emerging health needs. Yet there is no standard definition of an LDT across APAC markets.
District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead? | JD Supra
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case that consolidated two sets of challenges to the validity of FDA’s final rule on the regulation of laboratory developed tests (“LDTs”). Citing the Supreme Court’s decision in Loper Bright Enterprises v.
EXPERT INSIGHTS-FDA ISSUES DRAFT GUIDANCE DESCRIBING WHEN A CONFIRMATORY TRIAL OF A DRUG SEEKING ACCELERATED APPROVAL IS 'UNDERWAY'
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FDA Issues Draft Guidance Describing When A Confirmatory Trial Of A Drug Seeking Accelerated Approval Is "Underway"
In recent years, Congress and the U.S. Food and Drug Administration ("FDA") have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic benefit to patients over existing treatments for serious or life-threatening illnesses or conditions.
Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance on Requirements and Processes for Accelerated Approval | JD Supra
On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval endpoints and confirmatory trials as well as FDA’s process for withdrawing accelerated approval (the “Draft Guidance”).
Three Of A Kind: FDA Guidance Documents Provide Recommendations On Non-Traditional Clinical Trial Designs
RG Ropes & Gray LLP More Ropes & Gray is a preeminent global law firm with approximately 1,400 lawyers and legal professionals serving clients in major centers of business, finance, technology and government. The firm has offices in New York, Washington, D.C., Boston, Chicago, San Francisco, Silicon Valley, London, Hong Kong, Shanghai, Tokyo and Seoul.
Three of a Kind: FDA Guidance Documents Provide Recommendations on Non-Traditional Clinical Trial Designs
On September 16-17, 2024, FDA issued three guidance documents (one final and two drafts) as part of the Agency’s ongoing efforts to modernize its policies for the conduct of clinical trials.
Regulation Without Legislation: FDA Proposes Rule To Regulate Laboratory Developed Tests And End Historical Enforcement Discretion Policy
On September 29, 2023, the U.S. Food and Drug Administration ("FDA") released a proposed rule that would affirm FDA's position that laboratory developed tests ("LDTs") are in vitro diagnostic products ("IVDs") regulated as medical devices under the Federal Food, Drug, and Cosmetic Act ("FDCA").
Al-Quriqchee v. Majorkas et al
Petitioner: Hussein Al-Quriqchee Respondent: Alejandro Majorkas, Ur M Jaddou, Margaret Rosenast and United States Citizenship and Immigration Service Case Number: 3:2023cv01402 Filed: September 26, 2023 Court: US District Court for the District of Oregon Presiding Judge: Stacie F Beckerman Nature of Suit: Naturalization, Petition for Hearing of Denial Cause of Action: 8 U.S.C. ยง 1447 Hearings on Denials of Applications for Naturalization Jury Demanded By: None RSS Track this Docket This...
A Step Forward: FDA Issues Three Draft Guidance Documents As Part of Efforts to Modernize the 510(k) Notification Pathway
On September 7, 2023, FDA issued three new draft guidance documents intended to strengthen the 510(k) premarket notification pathway for medical devices. They address: Best practices for selecting a predicate device to support a 510(k) submission (the “Predicate Device Draft Guidance”); Recommendations for the use of clinical data to support a 510(k) submission (the “Clinical Data Draft Guidance”); and Evidentiary expectations for 510(k) implant devices (the “Implants Draft Guidance”).
A step forward: FDA issues 3 draft guidance documents as part of efforts to modernize the 510(k) notification pathway
(September 28, 2023) - Ropes & Gray attorneys Greg Levine, Joshua Oyster and Michael Purcell discuss three draft guidance documents the Food and Drug Administration issued to modernize the medical device marketing authorization pathway under Section 510(k) of the Food, Drug and Cosmetic Act. On September 7, 2023, FDA issued three new draft guidance documents intended to strengthen the 510(k) premarket notification pathway for medical devices.
Leveraging License Plate Recognition (LPR) Data for Enhanced Corporate Security
By Michael Purcell Jump to: In the rapidly evolving realm of corporate security, organizations are continuously seeking innovative solutions to safeguard their assets, employees, and customers. One technology that has emerged as an invaluable tool for corporate security departments is License Plate Recognition (LPR) data. LPR systems capture and analyze vehicle license plate information, offering a wealth of data that significantly enhances security measures.
Abdulsalam v. Majorkas et al
August 3, 2023 Filing 2 Proposed Summons for respondent Alejandro Majorkas (Attachments: #1 Proposed Document Respondent Uri M. Jaddou, #2 Proposed Document Respondent Margaret Rosenast, #3 Proposed Document Respondent USCIS) Filed by Naseer M. Abdulsalam. (Purcell, Michael) August 3, 2023 Filing 1 Complaint. Filing fee in the amount of $402 collected. Agency Tracking ID: AORDC-9035941 Jury Trial Requested: No. Filed by Naseer M.
What is the INFORM Consumers Act?
Online marketplaces have become a popular choice for online consumer shopping due to their convenience and ease of use, allowing people to shop from the comfort of their own homes. These marketplaces differ from traditional online retailers, making them all the more appealing to creative artists and entrepreneurs who can sell their products without incurring the costs of opening a physical store or building a website from scratch.
Synthetic Identity Fraud: What is it and How to Combat it
What is Synthetic Identity Fraud? Synthetic Identity is the fastest growing form of identity theft with losses in the multi-billions! Over 80% of all new account fraud can be attributed to synthetic identity fraud. Synthetic identity fraudsters are tricky and sophisticated. They use a combination of real data and fictitious data to create a new identity.
Closer to Normalcy: FDA Finalizes Transition Plans for Medical Devices Marketed Under COVID-19 Emergency Policies
On March 27, 2023, FDA issued two final guidance documents providing transition plans for medical devices that FDA allowed to be marketed during the COVID-19 pandemic: the “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)” (“EUA Transition Plan”) and the “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”...
Hasan et al v. Majorkas et al
March 10, 2023 Filing 3 Proposed Summons Respondent Alejandro Majorkas (Attachments: #1 Proposed Summons Respondent Uri M. Jaddou, #2 Proposed Summons Respondent Margaret Rosenast, #3 Proposed Summons Respondent USCIS) Filed by Sattar Z Hasan, Balbool Hayfaak. (Purcell, Michael) March 10, 2023 Filing 2 Civil Cover Sheet regarding Complaint, #1 . Filed by Sattar Z Hasan, Balbool Hayfaak. (Purcell, Michael) March 10, 2023 Filing 1 Complaint. Filing fee in the amount of $402 collected.
Using a SAT Solver to Find Interesting Sets of Nonstandard Dice
Abstract Formulae display:? Abstract We describe a family of Boolean satisfiability (SAT) problems for which each solution corresponds to a unique set of nonstandard dice. We show that we can control the relationships between the dice in each solution by imposing a set of cardinality constraints on the variables in the corresponding SAT problem. We then present examples of interesting sets of nonstandard dice that we found by solving such problems.
Know how to assess your data partner
Financial institutions Locating high-quality data can be a vital turning point in an investigation. It can even prevent criminal activity, terrorism, and fraud from happening in the first place. But how do you find that critical information? Many industries look to outside vendors to manage their data quality. With the global datasphere projected to hit 175 zettabytes by 2025, knowing how to assess your data partner is paramount to being able to evaluate risk within your organization.
Local For Sale: Danish Trundle Bed $225
Skip to main content This post was contributed by a community member. The views expressed here are the author's own. This European Trundle bed has a low, wheeled bed that is stored under the top twin/single bed. It can be rolled out for use as either storage space or as another guest bed. Both mattresses are clean (of stains or oder). The wood finish is in excellent condition. A perfect fit for use in a small bedroom/office space. More Classifieds Business Update Home Match Contra Costa County
Prediction, Prevention and Proof
Artificial Intelligence and Peace Bonds in Canada Michael Purcell Ontario Ministry of the Attorney General Mathew Zaia Ottawa Law Review Keywords: Criminal Law, Criminal Procedure, Police Powers, Evidence, Admissibility, Peace Bonds, Artificial Intelligence, Predictive Technology, AI, Preventative Justice, Pre-Crime Policing, Civil Liberties Abstract The current trajectory of predictive artificial intelligence and algorithms suggests that their introduction into Canadian criminal courts is...
A Shifting Landscape
To print this article, all you need is to be registered or login on Mondaq.com. In the months since the novel coronavirus (SARS-CoV-2) first appeared in the United States in late 2019, private industry and governmental authorities have recognized and responded to the need to develop and scale up manufacturing of COVID-19 vaccines, diagnostics, therapeutic treatments, and even basic medical supplies.
Pandemic May Spur Reform Of Lab Test Regulation
By Beth Weinman, Gregory Levine and Michael Purcell April 7, 2020, 1:44 PM EDT Law360 (April 7, 2020, 1:44 PM EDT) -- Beth Weinman Gregory Levine Michael Purcell On March 5, a bipartisan group of legislators introduced the Verifying Accurate, Leading-edge IVCT Development, or VALID, Act of 2020 in both the U.S. House of Representatives and Senate.[1] The bill seeks to create a framework for U.S. Food and Drug Administration regulation of a new category of medical products known as in vitro...
Batting for humanity in the curriculum
Did you know that the most recognised song in the world, ‘Happy birthday to you’, was written and composed by two sisters who were school teachers? I learned this fact from Anil Srinivasan, who recently gave a brilliant lecture, Music and the Brain, at the TAISI Conference in Bengaluru. Srinivasan argued that music should be included in every lesson, and he showed us how.
Stoke the FIRE
We need ‘humanity’ in the classroom, and teachers trained in modern methods Did you know that the most recognised song in the world, ‘Happy birthday to you’, was written and composed by two sisters who were school teachers? I learned this fact from Anil Srinivasan, who recently gave a brilliant lecture, Music and the Brain, at the TAISI Conference in Bengaluru. Srinivasan argued that music should be included in every lesson, and he showed us how.
Campus Carry: Options for Staying Safe at College
Plenty of people have shared the horror stories of going to college: winding up with a terrible roommate, showers shared with dozens of people, etc. But nobody is addressing the real horrors. College campuses are common targets for mass murderers. Campuses not only provide a dense population, but most are gun-free zones. How do individuals protect themselves on campus when protection isn’t allowed?
The Canadian Bar Review
Current Issue Vol 98 No 3 (2020) Published: 2020-12-11 Articles Book Reviews Case Comments View All Issues Founded in 1923, the Canadian Bar Review is the bilingual peer-reviewed legal journal of the CBA, where theory and practice meet. Its mission is to serve the legal profession, the bench, the bar, and the academy by publishing the highest quality legal scholarship that will shape discussion on the most relevant legal issues of our time.
COLUMN: Charity Newsies one of Lancaster-Fairfield County's great success stories
During this “most wonderful time of the year,” I wanted to take a moment and say “thank you” to each of the incredible donors, supporters, and volunteers who make the Charity Newsies a true Success Story. Last year the Charity Newsies provided 400 plus families with food supplies during the holiday season.
Cumann na mBan
In 1983 I presented the following to the Kilmainham Jail Restoration Committee, where it hangs to this day. As far as I know it was one of the first attempts by anyone to write a history of the Cumann. Extracts from this history formed part of the obituary of Mary Malone, the last surviving member of Carlow / Laois Cumann na mBan, who died in 1997.
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