News & Analysis as of

Life Sciences Investigations

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

K&L Gates LLP

FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

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In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation...more

McDermott Will & Emery

[Hybrid Event] Healthcare Litigation, Compliance and Investigations Forum 2023 - November 1st, Chicago, IL

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McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in Life Sciences and Healthcare Enforcement: Understanding and...

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

Hogan Lovells

Collaborative research is blurring boundaries between sponsored studies and IIS

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Industry is revising its models in clinical development: new collaborative research between the industry and investigators is becoming more important, resulting in an in-between approach between industry sponsored studies and...more

Jackson Walker

Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements

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Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - March 2023

Circuits Split Over Whether Targeting Is Necessary for Seller Liability - Key Points - - While courts have long held that solicitations must be tailored to a particular audience to precipitate statutory seller liability,...more

Dechert LLP

Dechert's Global Private Equity 2022 Highlights

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Despite rising interest rates, global geopolitical risk and uncertainty surrounding a looming recession, 2022 remained a robust and fascinating year for the PE industry. Dechert’s PE practice worked alongside our clients...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

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On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - February 2021

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

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook

On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more

Latham & Watkins LLP

A Look Ahead at the Biden Administration’s Regulatory and Enforcement Priorities

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With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more

Adler Pollock & Sheehan P.C.

Driving Revenue And Deal Flow Through An Intelligent IP Strategy; Strategies For Smaller And Early-Stage Life Science Companies....

As discussed in Part I, a company’s technology must have strong intellectual property to establish a significant technology transfer program or prepare for an eventual acquisition. Establishing an intelligent IP strategy can...more

King & Spalding

FDA Issues Final Rule and Guidance Creating New Standards for the Acceptance of Data Obtained from Clinical Investigations...

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On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements...more

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