The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting, including a...more
The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating randomized controlled...more
The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” which outlines the...more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) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at...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Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.”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
On November 29 and 30, the U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative, hosted a public workshop on ways to increase the enrollment of historically...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
Continuing the trend over the past few years to promote diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has published new draft guidance on “Postmarketing Approaches to Obtain Data on Populations...more
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance on Good Clinical Practice (GCP), adopting the International Council for Harmonisation’s (ICH) “E6(R3)” guidelines.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
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
The U.S. Food and Drug Administration (FDA) recently issued the Federal Register notice “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” which aims to help facilitate the...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
Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal Policy for the Protection of Human...more
On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to FAQs about FDA’s policies for charging...more
On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more
A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
8/13/2021
/ Biotechnology ,
Drug Approvals ,
Drug Compounding ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Genus ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Public Comment
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
The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or a “device,” FDA does not...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs. ...more
In Tuesday's Report: FDA warns over drug misbranded as COVID-19 treatment; podcast discusses Trump's "Buy American" executive order; an op-ed on the importance of protecting biomedical innovation; HHS sees high level...more
10/26/2020
/ Biopharmaceutical ,
Buy America ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Life Sciences ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Trump Administration