fda – Duane Morris Life Sciences Law

The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health technologies. By exercising enforcement discretion, FDA would allow device manufacturers to forego certain marketing requirements, such as labeling and premarket authorization, while participating in the pilot program.

Read the full Alert on the Duane Morris LLP website.

October 22, 2025 by Duane Morris

Replay: Wearables Webinar Series, Part 2: Cybersecurity and Data Privacy Concerns for Wearables

A replay of “Wearables Webinar Series, Part 2: Cybersecurity and Data Privacy Concerns for Wearables” is now available for viewing.

October 22, 2025October 22, 2025 by Duane Morris

Replay: Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables

A replay of “Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables” is now available for viewing.

October 8, 2025October 8, 2025 by Duane Morris

Wearables Webinar: Cybersecurity and Data Privacy Concerns for Wearables

Duane Morris will host the second session of its Wearables Webinar Series, Cybersecurity and Data Privacy Concerns for Wearables, on Tuesday, October 21, 2025, from 12:00 p.m. to 12:30 p.m. Eastern.

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About the Program

The growing popularity of wearable devices that track consumers’ everyday health has been good for business. It has also resulted in increased concerns from regulators regarding the privacy and security of the health data and other personal information collected and used by wearable technologies. In our second wearables webinar, Duane Morris partner Michelle Hon Donovan will discuss:

Privacy legal compliance landscape under state and federal laws and regulations
FDA cybersecurity guidance
Federal and state breach notification laws
Key takeaways and best practices for compliance

About the Webinar Series

Over a series of three mini-webinars, Duane Morris attorneys will offer high-level guidance on current FDA regulations, cybersecurity and data privacy, and product liability and IP strategies for wearables.

Upcoming Webinar Sessions:
November 4, 2025 – Product Liability and IP Strategies for Wearables

About the Duane Morris Life Sciences and Medical Technologies Group

As biotech, biopharma and pharma companies develop new therapeutics, aligning legal strategies with development and commercialization goals throughout the extensive process of funding, R&D, clinical trials and market entry is imperative to a company’s strategy, success and growth. We assist clients in developing and implementing strategies to protect and expand their pipeline and maximize the benefit of their products to their target patient population.

May 22, 2025 by Duane Morris

Montana Set to Become a “Wild West” Hub for Experimental Medical Treatments and Therapies

By Vicki G. Norton, Ph.D., and Brandon A. Chan Ph.D.

The Federal Food, Drug and Cosmetic Act generally prohibits access to investigational drugs that have not yet been approved by the United States Food and Drug Administration. Patients that have been diagnosed with a life-threatening or seriously debilitating disease may request “expanded access” or compassionate use to gain access to investigational drugs pending FDA’s permission. Right-to-try laws seek to bypass the FDA’s more rigorous requirements for expanded access and permit terminally ill patients to access investigational drugs, biologics and devices that have completed Phase I but have yet to receive FDA approval. Today, most states have enacted some form of a right-to-try law, and a federal Right to Try Act was enacted in 2018. Recently, Montana has sought to further expand access to experimental treatments.

Read the full story on the Duane Morris LLP website.

February 12, 2025February 12, 2025 by Duane Morris

FDA Releases Draft AI Guidance – A New Era for Biotech, Diagnostics and Regulatory Compliance

The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism. As AI increasingly permeates these fields, the regulatory landscape is just beginning to take shape—and these proposed guidelines take a step in that direction by raising awareness of important questions about the future of AI innovation in life sciences. For therapeutic, medical device and diagnostics companies—whether already implementing AI or just beginning to explore its potential—the message is clear: The landscape is evolving, and future success will require thoughtful consideration of compliance, patient safety and privacy protection from the earliest stages of AI adoption.

Read the full Alert on the Duane Morris LLP website.

January 23, 2025January 23, 2025 by Duane Morris

Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient

In Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC (No. 2024-1936), the Federal Circuit affirmed the District Court of New Jersey’s order to delist from the FDA Orange Book Teva’s five patents claiming just device components of a drug product without reciting any active ingredient.

Read the full Alert on the Duane Morris LLP website.

October 21, 2024October 21, 2024 by Duane Morris

FDA’s Final Guidance on Decentralized Clinical Trials Published

On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using telehealth appointments, outsourcing visits to local healthcare providers, or conducting laboratory tests at outside facilities.

Read the Alert on the Duane Morris LLP website.

September 23, 2024 by Duane Morris

FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and the Office of Combination Products in the Office of the Commissioner worked together to prepare this Guidance.

Read the full Alert on the Duane Morris LLP website.

July 15, 2024 by Duane Morris

Induced Infringement Suit Against Generic Pharma Revived Despite Skinny Label Compliance

In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone did not, as a matter of law, recommend, encourage or promote any infringing use.

Read the full Alert on the Duane Morris LLP website.