News & Analysis as of

Medical Devices Prescription Drugs Informed Consent

Quarles & Brady LLP

Med Spa Compliance Series: Area of Focus – Good Faith Examination

Quarles & Brady LLP on

As individuals across the country become increasingly focused on their health and wellness, the 20-billion-dollar med spa industry continues to grow. Patients are now visiting their med spa more than their primary care...more

Nelson Mullins Riley & Scarborough LLP

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

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

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

Wilson Sonsini Goodrich & Rosati

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

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials.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

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