August 2020 – Duane Morris Life Sciences Law

August 27, 2020August 27, 2020 by Duane Morris

New Guidance Reveals FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

To read the full text of this Duane Morris Alert, please visit the firm website.

August 6, 2020 by Duane Morris

FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products

On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to the manufacturing and marketing of “multiple function” device products—products comprised of at least one FDA-regulated “device” function and at least one “other function”—a function that either does not meet the definition of a “device” under the Federal Food, Drug & Cosmetic Act; that is not subject to premarket approval; or for which the FDA has expressed an intention not to enforce regulatory compliance.

To read the full text of this Duane Morris Alert, please visit the firm website.