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Williams Mullen's COVID-19 Comeback Plan: Part II – Doing Business With the Commonwealth of Virginia
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The US Food and Drug Administration (FDA) recently announced its qualification of the Apple Atrial Fibrillation (AFib) History Feature through the Medical Device Development Tools (MDDT) program. The MDDT program is intended...more
The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...more
Although legal fees spent preparing Paragraph IV notice letters must be capitalized (and thus amortized over 15 years), legal fees spent defending ANDA suits launched in response to those letters may be taken as deductions in...more
In a decision characterized by the National Milk Producers Federation as a "momentous victory for American consumers, farmers and food manufacturers" and a "huge victory for worldwide producers" of gruyere cheese, the U.S....more
An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more
In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...more
On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products...more
The U.S. is a step closer to enacting a consistent, national approach to certifying and labeling genetically modified (GMO) foods. On July 23, 2015, the U.S. House of Representatives passed H.R. 1599, the Safe and Accurate...more
In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a...more