The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”) (87 Fed. Reg. 75608 (December 9, 2022)) (the “Notice”) to
Life Sciences Perspectives
Life Sciences Perspectives, published by Goodwin Procter, focuses on legal and regulatory developments affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotechnology transactions, regulatory compliance for drugs, biologics, medical devices, diagnostics, and laboratory testing. It also addresses antitrust issues, healthcare fraud enforcement, data privacy regulations like the EU Data Act, and FDA programs impacting drug development and approval. The blog provides updates on policy changes, enforcement trends, and strategic considerations for companies and investors operating in the life sciences and medtech industries.
Latest from Life Sciences Perspectives - Page 13
USPTO and FDA Continue to Focus on Patent Quality in the Pharmaceutical Industry
After a recent reminder from the U.S. Patent and Trademark Office (USPTO) regarding the duties of disclosure and reasonable inquiry during examination of a patent application and a Request for Comments (RFC) on the USPTO initiatives to ensure “robustness and…
Avoiding Misbranding: Words Matter When Describing the Regulatory Status of 510(k) Cleared Devices and Registered Device Establishments
When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning. Similarly, creating an impression of approval of…
Five Key Regulatory Considerations for Virtual Ketamine Clinics
The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a full suite of health care services, including telehealth…
Antitrust & Competition Life Sciences Quarterly Update Q3 2022
The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays. That said, even these inherently procompetitive deals…
FDA Announces Total Product Life Cycle Advisory Program (TAP) Pilot
The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase of this voluntary initiative, called TAP…
United States: FTC Looks Set To Open Up New Enforcement Front (Global Competition Review)
Recent merger enforcement in the pharmaceutical space continues to follow traditional principles and modes of analysis. However, with a new 3-to-2 Democratic majority, it is increasingly likely that the Federal Trade Commission’s enforcement actions will reflect more aggressive theories that…
FDA Issues Final Clinical Decision Support Software Guidance
On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the Agency’s September 2019 draft guidance of the same name…
USPTO Doubles Down Calling Out Pharmaceutical Industry
The new Director of the U.S. Patent and Trademark Office (USPTO), Katherine Vidal, published a stern reminder regarding the duties of disclosure and reasonable inquiry during examination of a patent application, including reexamination, reissue, and proceedings before the Patent Trial…
Restructuring and Insolvency in the Life Sciences Sector: Q&A
Goodwin’s Financial Restructuring partner Simon Thomas and counsel Oonagh Steel, with contributions from Life Sciences partners Sophie McGrath, Andrew Harrow and Tim Worden, have recently published a piece of thougtht leadership titled “Restructuring and insolvency in the life sciences sector:…