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Medical Devices › Pharmaceutical Industry › Informed Consent

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

Nelson Mullins Riley & Scarborough LLP

FDA Finalizes Informed Consent Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more

Patrick Malone & Associates P.C. | DC Injury...

For patients’ sake, U.S. must slap down Big Pharma chiseling on tests, trials

Patrick Malone & Associates P.C. | DC Injury... on

Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard....more

Patrick Malone & Associates P.C. | DC Injury...

Concerns rise over costly emergency intervention — a ‘bridge to nowhere?’

Patrick Malone & Associates P.C. | DC Injury... on

Medical ethicists and patient advocates are raising concerns about a big, costly, and often unsuccessful procedure that “pumps blood out of the body, oxygenates it, and returns it to the body, keeping a person alive for days,...more

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

Morgan Lewis

International Life Sciences Data Transfers After Schrems

Morgan Lewis on

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

Wilson Sonsini Goodrich & Rosati

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

Wilson Sonsini Goodrich & Rosati on

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Foley Hoag LLP

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

Foley Hoag LLP on

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

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