Tag Archives: fda

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.

Click here to read the full Alert.

Attention mHealth, HIT and Telemedicine App Developers: Privacy and Security By Design Is Critical

Mobile health (“mHealth”) medical app developers, including health information technology (“HIT”) and telemedicine app developers, tend to focus on FDA requirements. Indeed since many of these apps may be categorized as medical devices, and the FDA approval process is lengthy, developers are wise to focus on whether an app is regulated by the FDA. But a successful developer should also build privacy protections (e.g., privacy policies) and security protections (e.g., disaster recovery) into its product from the earliest stages. The Federal Trade Commission (“FTC”) calls this “Privacy By Design.” “Security By Design” is the corollary. Continue reading Attention mHealth, HIT and Telemedicine App Developers: Privacy and Security By Design Is Critical

mHealth/Telehealth Investors and Entrepreneurs: The Generational Divide

Mobile health (“mHealth”, “telehealth” or any other terms for health care delivered wirelessly) is revolutionizing the health care industry. That message resounded at last week’s mHealth Summit, which gathered roughly 4,000 investors and angel-funders, telecom and software companies, and entrepreneurs and developers to share ideas and display new mHealth products. Hot mHealth areas include data analytics, texting and medical records. Home health and medical homes also stand to benefit with the introduction of products designed to submit protected health information (“PHI”) and other data between patient and provider. Continue reading mHealth/Telehealth Investors and Entrepreneurs: The Generational Divide

My Doctor The Car – How Mobile Health (Mhealth) Technologies Are Radically Re-Envisioning Health Care

‘Mobile health’ (mHealth), which is defined loosely as health care delivered wirelessly, is set to transform health care. A perfect example is the Ford Motor Company’s ‘Car That Cares,’ which it announced at the 2012 International Consumer Electronics Show in Las Vegas in January. The car’s in-vehicle health monitoring system was developed through a collaboration with Microsoft, BlueMetal Architects, and Healthrageous and is designed to support passengers’ personal health and disease management programs. The vehicle’s dashboard is equipped to collect real time biometric and other data, along with voice inputs, to help the passenger comply with his or her health and wellness program through digital coaching (“How much did you eat for breakfast? Did you take your pills?”). The system can also wirelessly connect to other health-related smartphone apps and portable medical devices such as a car seat that measures blood pressure, to alert the passenger to health changes. These apps and devices can then connect to the passenger’s health care provider and electronic health record. The Car That Cares is still in the research phase, giving the public and the regulators time to catch up with this new concept.

Continue reading My Doctor The Car – How Mobile Health (Mhealth) Technologies Are Radically Re-Envisioning Health Care