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FDA Remote Regulatory Assessments Are Not So Remote Anymore

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

FDA Launches the Center for Clinical Trial Innovation

Building on CDER's efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct....more

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

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

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

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

FDA on Board With Continuing Remote Inspections

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

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

Senate Judiciary Committee Revisits Drug Pricing Reform Bills

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

FDA Proposes IND Exemptions for Drug Studies of Foods, Supplements, or Cosmetics

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

White House Guidance on Implementing NSPM-33: Standardization of Disclosure and Security Measures for Federal Research Funding

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 PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes [Video]

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

JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials [Video]

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

JONES DAY PRESENTS® Digital Health: Current Trends and Legal Issues [Video]

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

Telemedicine and the Coronavirus Crisis: Key Legal Issues for Providers to Consider

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 TALKS®: COVID-19: Key Considerations for Health Providers & Life Science Companies [Audio]

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

Steps Companies Should Take to Protect Themselves from the Legal Fallout of the Coronavirus

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

FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials

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

FDA Releases Software Precertification Working Model

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

FDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device

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

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

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

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

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

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

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

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

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

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

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

FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

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

Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

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

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