The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
Building on CDER's efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct....more
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more
2/22/2024
/ Comment Period ,
Draft Guidance ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Remote Proceedings
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting...more
On January 4, 2022, the White House Office of Science and Technology ("OSTP") released guidance for federal agencies to implement National Security Presidential Memorandum 33 ("NSPM-33"). Issued in the final days of the Trump...more
Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more
6/29/2020
/ Clinical Trials ,
Data Privacy ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
New Regulations ,
Pharmaceutical Industry ,
Privacy Laws ,
State Regulators ,
Technology ,
Telemedicine
Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more
6/2/2020
/ Biometric Information ,
Clinical Trials ,
Consent ,
Data Collection ,
Data Integrity ,
Data Privacy ,
Data Security ,
Digital Health ,
Health Care Providers ,
Health Technology ,
Research and Development
The adoption of digital health technologies introduces a new range of efficiencies for health care delivery and marks a significant breakthrough in research and development capabilities for the life sciences industry. Jones...more
The Situation: As the outbreak of the novel coronavirus disease (COVID-19) continues, telemedicine platforms are ideally situated to coordinate care and minimize exposure, while advancing access to care.
The Action:...more
Jones Day partners Alexis Gilroy and Maureen Bennett talk about lessons already learned from COVID-19, the questions clients are asking, why it's important that the world's health care organizations share information, and how...more
The novel coronavirus (COVID-19) outbreak, first identified in Wuhan, China, has spread beyond China's borders to dozens of countries, infecting tens of thousands of people and causing a mounting number of fatalities. In...more
3/9/2020
/ Best Practices ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Employer Liability Issues ,
Force Majeure Clause ,
Infectious Diseases ,
Policies and Procedures ,
Public Health ,
Publicly-Traded Companies ,
Risk Management ,
Transportation Industry ,
Traveling Employee ,
Workplace Safety
The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses.
The Development: The U.S. Food and Drug...more
On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert") Pilot Program. The Pre-Cert Program is an effort by FDA to develop a new, more...more
On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition. The device, called IDx-DR, utilizes an...more
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain.
The...more
In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more
June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more
On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more
On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more
6/30/2017
/ Canada ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Imports ,
Legislative Agendas ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OMB ,
Pharmacies ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more
The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more