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Exponent
On Nov. 17, the Food and Drug Administration released the final guidance for assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions.
Jones Day
In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts.
Akin Gump Strauss Hauer & Feld LLP
A divided panel of the Federal Circuit affirmed a district court's grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval based on the particular facts of this case.
Exponent
Four questions for developing inclusive digital solutions by identifying women-specific requirements and endpoints
Goodwin Procter LLP
Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy's Laboratories ("DRL") and Fresenius Kabi.
Farrell Fritz, P.C.
We live in an age of scientific miracles. We have an unprecedented ability to identify the causes of disease, and we have access to treatments, and even cures, we could not imagine only a few decades ago.
Exponent
Final rule requires a 90% reduction in ethylene oxide emissions from commercial medical device sterilization facilities...
Mintz
Of Counsel Benjamin Zegarelli and Associate Pat Ouellete discussed the health care regulations governing medical devices and software and shared how to stay informed and navigate the evolving landscape of health care regulations.
Exponent
The agency has published new draft guidance to support manufacturer compliance with special controls...
WilmerHale
Partner Sarah Hogan has contributed to American Health Law Association's second edition of Health Care Contracts: A Clause-by-Clause Guide to Drafting and Negotiation...
Buchanan Ingersoll & Rooney PC
Last week, the Federal Circuit held an oral argument that may have future implications for Section viii Carve-Outs in Amarin Pharmaceuticals, Inc. v. Hikma Pharmaceuticals...
Axinn Veltrop & Harkrider
Among the most established standards in patent law is that obviousness requires a motivation to combine the prior art with "a reasonable expectation of success."
Diaz Trade Law
Last week, FDA's Center for Tobacco Products (CTP) announced the release of its Searchable Tobacco Products Database.
Goodwin Procter LLP
On April 4, 2024, Bristol Myers Squibb ("BMS") and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed ...
Dickinson Wright PLLC
The Food and Drug Administration regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics.
Goodwin Procter LLP
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo's ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Arnold & Porter
There are several aspects of the pharmaceutical industry's potential environmental footprint. Research and development require sophisticated equipment, controlled environments, and specialised materials.
Jones Day
In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall...
Arnold & Porter
In an effort to limit challenges for patient access, patient adherence to recommended treatment, or adoption of innovative products and services, providers, suppliers, and product manufacturers seek ways to address such roadblocks.
Arnold & Porter
11. COVID-19 and Life Sciences, the US government has used a wide variety of
public procurement and funding strategies for needed medical
countermeasures during the pandemic.
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