Duane Morris attorneys Rick Ball and Coleen Hill will speak at the MassMedic Regulatory Roundup Event webinar on February 16, 2023, starting at 9 a.m. Their presentation is titled “Recent Developments on the ‘Fraud on the FDA’ Theory of False Claim Liability” at 10:45 a.m. This program is designed to give RA, QA and C-level ..read more

On December 23, 2022, Congress significantly expanded the FDA’s regulatory authority over cosmetics as part of its year-end Consolidated Appropriations Act of 2023, the first major statutory change to the Food, Drug and Cosmetics Act regarding the regulation of cosmetics since 1938. Passed with bipartisan support and garnering industry approval, the Modernization of Cosmetics Regulation ..read more

The Antitrust Division of the Department of Justice (DOJ) has indicated a recent interest in enforcing Section 8 of the Clayton Act, which prohibits individuals from serving on boards of competing corporations, known as “interlocking directorates.” (See 15 U.S.C. § 19.) Assistant Attorney General Jonathan Kanter has called Section 8 an “important but underenforced” antitrust law. After DOJ announced ..read more

On September 15, 2022, Deputy Attorney General Lisa O. Monaco of the Department of Justice (DOJ) delivered a speech at New York University addressing new guidance on corporate criminal enforcement. Her speech made it clear that DOJ is prioritizing investigations and prosecutions against corporate entities. DOJ’s approach in this area is fundamentally grounded in individual ..read more

Parties in the discovery phase of litigation often exchange confidential documents and information, which may contain proprietary information such as the technical aspects and know-how behind a party’s intellectual property. To facilitate the exchange of confidential information and prevent its misuse by parties to the litigation, courts often use an agreed protective order, which outlines ..read more

The backlog of pending patent applications at the USPTO is growing. As of May 2022, the USPTO estimates an average pendency of approximately 20 months from filing to the mailing of a first office action. Applicants may be tempted to take advantage of and exploit the patent system to unreasonably delay prosecution and extend the ..read more

On April 13, 2022, the FDA issued Guidance for Industry #256 about the enforcement policy regarding the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or pharmacists in either state-licensed pharmacies or federal facilities. FDA has spent several years and gone through multiple iterations trying to develop new industry ..read more

On October 28, 2021, Deputy United States Attorney General Lisa Monaco issued a memorandum marking the first major announcement on corporate criminal enforcement from the Department of Justice (“DOJ”) under the Biden Administration (“Monaco Memo”). Most notably, this memorandum: (1) reinstates the Individual Accountability Policy originally announced in the Yates Memo and (2) guides prosecutors ..read more

On August 2, 2021, the Food and Drug Administration issued its final rule modifying its regulations on the intended use of medical devices, prescription drugs and biologics. Most importantly, the final rule repeals the 2017 rule’s “knowing clause,” which seemed to imply that a party may be accountable for off-label use if the party “should ..read more

By Stephen M. Honig Duane Morris supports a proprietary platform in Boston that permits emerging life science and med device companies to pitch to a varied group of investors, from qualified angels to major pharmas. We also represent companies seeking financing and independent investors in this space. In assisting in due diligence during the first ..read more