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Life Sciences › Institutional Review Board (IRB) › Food and Drug Administration (FDA)

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

Ropes & Gray LLP on

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Health Care Compliance Association (HCCA) on

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Jones Day

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

Jones Day on

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

Hogan Lovells

Informed consent duties for IRBs, investigators, and sponsors detailed in FDA final guidance

Hogan Lovells on

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

Knobbe Martens

FDA Issues Updated Informed Consent Guidance for Clinical Investigations

Knobbe Martens on

On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...more

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

K&L Gates LLP

Health Care Triage: Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

K&L Gates LLP on

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more

Snell & Wilmer

Adapting Clinical Research During the COVID-19 Pandemic

Snell & Wilmer on

Many sectors of the economy have ground to a halt in the effort to curtail the COVID-19 pandemic (the “Pandemic”), and the clinical research industry is not immune to the effects of these business shutdowns. While the...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Mintz - Health Care Viewpoints on

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

Hogan Lovells

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

Hogan Lovells on

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

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