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Clinical Trials Waivers

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Goodwin

FDA Answers New Questions on Foreign Trial Sites Operating Under INDs

Goodwin on

On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more

Hogan Lovells

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

Hogan Lovells on

On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more

Bricker Graydon LLP

FDA proposes waiver of informed consent requirements for minimal risk trials

Bricker Graydon LLP on

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations...more

Hogan Lovells

Do the Waive – FDA Implements Informed Consent Waivers for Minimal Risk Studies

Hogan Lovells on

On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more

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