Frederick Ball – 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, 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.

February 24, 2025March 10, 2025 by Duane Morris

Federal Court Enjoins Enforcement of NIH’s Rate Change Notice Regarding Indirect Costs

By Dan Walworth, Rolando Sanchez, Frederick Ball, Geoffrey Goodale and Sara Smith

Since taking office, the Trump Administration has taken steps to reshape the United States’ federal funding infrastructure. One such action relates to the National Institutes of Health’s (“NIH”) rate change, imposing a 15% cap for indirect costs, for new grants and for existing grants awarded to institutions of higher education (“IHEs”). This rate change, which represents a drastic reduction from historical rates normally negotiated by grant recipients, will impact ongoing research programs and clinical trials, and will have a long-term impact on the United States’ research infrastructure and abilities.

On February 10, 2025, the day the rate change was intended to go into effect, three lawsuits were filed in the U.S. District Court for the District of Massachusetts challenging the rate change. The lawsuits were filed by a group of stakeholders, including twenty-two states, thirteen universities, three university associations and five associations. Also on February 10, 2025, a district court judge granted two temporary restraining orders (“TROs”), enjoining enforcement of the rate change within the 22 Plaintiff states, and enjoining enforcement nationwide with respect to institutions. On February 21, 2025, following a hearing on the Plaintiffs’ motions for injunctive relief, the district court ordered that the TROs entered on February 10, 2025 are extended and will remain in effect until further order of the Court.

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.

May 20, 2024 by Duane Morris

FDA’s New Rule Regulates Lab-Developed Tests Under FD&C Act

On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act (FD&C Act).

LDTs have increased in volume, complexity and importance in critical healthcare decision-making since 1976 when the Medical Device Amendments (MDA) were passed and FDA began exercising enforcement discretion. Accordingly, FDA has advised that increased oversight is needed for LDTs. However, some specific categories of LDTs will be covered under new targeted enforcement discretion policies.

Read the full Alert on the Duane Morris LLP website.

February 15, 2024 by Duane Morris

FTC Voices Support for March-In Rights on Patents to Help Control Drug Prices

The Federal Trade Commission (FTC) has announced its support of the federal government’s use of “march-in rights” as a mechanism to control the price of pharmaceuticals. The National Institute of Standards and Technology (NIST) late last year issued its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” that would fundamentally change the use of march-in rights by allowing the government to exercise price control under the Bayh-Dole Act, which the FTC announced its support for last week. This shift is the latest effort by federal agencies to lower drug prices in the wake of President Joe Biden’s Executive Order on Promoting Competition in the American Economy.

Read the full Alert on the Duane Morris LLP website.

October 16, 2023 by Duane Morris

Rick Ball and Coleen Hill to Speak at MassMEDIC Regulatory Roundup

Duane Morris attorneys Rick Ball and Coleen Hill will be speakers at MassMEDIC’s Regulatory Roundup, to be held on November 15, 2023 from 8:00 a.m. to 4:15 p.m. Rick and Coleen will present “When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved.” For more information and to register for this hybrid event, please visit the MassMEDIC website.

September 6, 2023 by Duane Morris

FDA’s Second Warning Letter of the Year Deals with Potentially Misleading Efficacy Claims About Inhaler

On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a warning letter to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure for its Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) inhalation aerosol contained false or misleading claims regarding the drug’s efficacy.

In view of the warning letter—only the second of the year issued by the Office of Prescription Drug Promotion (OPDP)—companies should review their promotional materials to confirm that any efficacy claims are clearly supported by cited data and do not give rise to misleading impressions and regulatory scrutiny—even where such materials are intended for patients.

Read the full Alert on the Duane Morris LLP website.