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2024 Credit Reporting Review: Impactful Changes and Future Forecast — FCRA Focus Podcast
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State AG Pulse | DEI in the Federal and State Spotlight
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#WorkforceWednesday®: Workplace Law Shake-Up - DEI Challenges, NLRB Reversals, and EEOC Actions - Employment Law This Week®
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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more
Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more
Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more
Welcome to the November-December edition of Akin Intelligence. As the end of 2024 approached, the European Union (EU) sustained progress on guidance and supporting materials for its AI Act and international AI Safety...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more
A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more
On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more
Following a public consultation period this summer, the European Medicines Agency (EMA) published revised transparency rules (s. here) for the EU Clinical Trials Information System (CTIS) on 6 October 2023. The CTIS serves as...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
On May 22, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) issued an untitled letter to AT Venture Center for Global Techtrepeneurship, LLC dba Regenerelle, LLC...more
The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode : Protection of vulnerable groups This part of the series is about the protection of the...more
MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more
Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more
The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more