Podcast - 2024 Election Impacts on Food and Agriculture Policy
The Privacy Insider Podcast Ep. 8: Privacy Over Party: Peter Swire
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
Election Roundup: How a Trump Administration Could Shape the Oil and Gas Landscape
Election Roundup: How a Harris Administration Could Shape the Oil and Gas Landscape
No Password Required: MITRE Engage Lead, Innovator in Cyber Deception, and Dance Community Builder
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
Clocking in with PilieroMazza: Second Chance Initiatives: Hiring Workers with Criminal Histories
State AG Pulse | Changing of the Guard in the PNW
Compliance Unveiled: 10 Must-Know Tips for the Pregnant Workers Fairness Act & Independent Contractor Rules
State AG Pulse | Never Say Never to Federal Privacy Legislation
La Reforma Pensional en Colombia
State AG Pulse | Everybody Comes From Somewhere
AI Law in the Commonwealth of Virginia - Recent Developments
The CFPB's Final Credit Card Late Fee Rule: Implications and Industry Response — The Consumer Finance Podcast and Payments Pros: The Payments Law Podcast
Leading With Purpose: Oregon AG Ellen Rosenblum Discusses Her Role at NAAG — Regulatory Oversight Podcast
State AG Pulse | The Election of the Double Haters
Exámenes de constitucionalidad a la reforma tributaria ¿en qué vamos?
Employment Law Now VIII-140 - 7th Anniversary Episode: The Current State of Politics for Employers
Excitement, Turbulence & Confusion: The Top 10 Employment Law Issues That Affected Federal Contractors in 2023
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 June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...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
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more
The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more
With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU....more
The UK Government has confirmed that it is committed to implementing the new EU Clinical Trials Regulation (EU) 534/2014 (“EU CTR”) into UK law post-Brexit. ...more
In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare...more