Distribution of Drug Samples During COVID-19: FDA Issues Temporary Policy

In response to the ongoing COVID-19 public health emergency, the United States Food and Drug Administration (FDA) issued a temporary policy related to the distribution of drug samples. Recognizing the unique challenges currently facing manufacturers that distribute drug samples as part of marketing efforts and the healthcare providers requesting those samples for patients, the FDA is temporarily easing certain requirements of the Prescription Drug Marketing Act.

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

FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

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

Mobile Medical Apps Guidance

Mobile health application developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration published its long-awaited final guidance on mobile medical applications under the Federal Food, Drug, and Cosmetic Act. It is vital for any app developer to understand whether the guidance applies to their product from the initial design stage. Those who are already marketing software and apps that involve healthcare should also review the guidance with care to try to determine how FDA’s new regime impacts both business plans and continuing operations.

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FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

The U.S. Food and Drug Administration (FDA) on July 15, 2013, released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA’s new authority to protect the integrity of the drug supply chain—specifically, Section 709 of the FDASIA [amending section 304(g) of the Food, Drug, and Cosmetic Act (FDCA)]. The proposed rules provide the FDA with the administrative authority to detain drugs the FDA believes are either adulterated or misbranded. The FDA will detain the drugs until it considers what action it should take concerning the drugs, whether legal or otherwise. The goal of this detention authority has been stated by the FDA as follows: “to protect the public by preventing distribution or subsequent of use of drugs … that are believed to be adulterated or misbranded … .” Comments on the proposed rule are due no later than September 13, 2013.

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