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Regulatory Oversight Life Sciences Compliance

Mayer Brown

Brasília em Pauta – Edição Nº 201

Mayer Brown on

Prezados e prezadas, O “Brasília em Pauta” é um boletim semanal preparado pela equipe de Contencioso de Brasília, contendo os principais casos a serem julgados pelo Supremo Tribunal Federal (STF), Superior Tribunal de...more

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Smart & Biggar

Evolving pharmacy landscape signals more stringent regulatory scrutiny of “patient steering”

Smart & Biggar on

The pharmacy landscape has evolved considerably over the past year, shining a spotlight on pharmacy “patient steering”, the practice of directing patients to certain preferred pharmacies. Though Quebec has long required that...more

Fenwick & West LLP

Key Takeaways from the UN Report: ‘Governing AI for Humanity’

Fenwick & West LLP on

The United Nations’ “Governing AI for Humanity” report published in September underscores existing guidance addressing the rapid advancements in artificial intelligence but also adds a focus on the need for a global...more

Arnall Golden Gregory LLP

Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Bass, Berry & Sims PLC

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

Bass, Berry & Sims PLC on

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

McDermott Will & Emery

[Event] Life Sciences Bootcamp For In-house Counsel - March 19th, Cambridge, MA

McDermott Will & Emery on

The life sciences industry faces a wide range of legal, regulatory and business challenges, along with constantly evolving trends that impact leadership priorities. McDermott’s cross-functional team of life sciences...more

McDermott Will & Emery

[Event] Life Sciences Bootcamp for In-House Counsel - July 18th, San Francisco, CA

McDermott Will & Emery on

McDermott’s cross-functional team of life sciences professionals present the inaugural Bay-Area Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. ...more

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