The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” which outlines the...more
The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small entities in complying with FDA’s LDT final rule, which...more
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more
Speaking at the J.P. Morgan Healthcare Conference this year, Hogan Lovells life sciences regulatory partners Lowell Zeta and Blake Wilson, were joined by Greenleaf Health’s Kalah Auchincloss, Executive Vice President,...more
Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.” In the...more
An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity. Innovators inspired by the promise of...more
The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as drafted) is intended to clarify the agency’s...more
Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final guidance supersedes FDA’s...more
On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program called Support for clinical Trials Advancing Rare...more
In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where the manufacturer of the IVD is a...more
The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers...more
The U.S. Food and Drug Administration (FDA) recently issued two discussion papers on the use of Artificial Intelligence (AI) and Machine Learning (ML) in the development of drug and biologics, and in the manufacturing of...more
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance on Good Clinical Practice (GCP), adopting the International Council for Harmonisation’s (ICH) “E6(R3)” guidelines. Below we summarize how the draft...more
The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more
The U.S. Food and Drug Administration (FDA) has several programs available that can expedite the development and regulatory review of a drug or biological product, including Accelerated Approval, which allows for approval of...more
U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more
In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms focused on FDA bundled under Title...more
The U.S. Food and Drug Administration (FDA) recently finalized the guidance “Multiple Endpoints in Clinical Trials,” which advises drug sponsors on how to separate analyses of primary endpoints – which are critical to showing...more
Earlier this year, the Delaware Chancery Court approved a breathtaking $237.5 million settlement of derivative claims brought against Boeing’s board for breach of fiduciary duties regarding safety oversight. While the Boeing...more
The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency (PHE) ends. This guidance...more
On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft guidance, “Diversity Plans to Improve Enrollment of...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more
8/5/2021
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Physicians ,
Product Labels
On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types ...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
2/25/2021
/ Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Product Labels ,
Public Health Emergency ,
Research and Development ,
Virus Testing