Host Mary O'Brien is joined by Wilson Sonsini technology transactions partner Gary Greenstein as she interviews SonyAI attorney and Wilson Sonsini alumna Tiffany Georgievski to discuss artificial intelligence (AI) and the...more
Host Mary O'Brien is joined by Wilson Sonsini corporate partner Craig Sherman as she interviews Bungie General Counsel Don McGowan to discuss forging strong attorney-client relationships. Conversation Highlights: Don...more
Host Mary O'Brien is joined by Wilson Sonsini technology transactions partner Barath Chari as she interviews Parth Naidu, founder and CEO at SIDO, an e-sports research group, to discuss the legal issues in e-sports gaming....more
On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more
Host Mary O'Brien interviews Wilson Sonsini partner Paul Gadiock exploring the convergence of the gaming and healthcare industries....more
Host Mary O'Brien interviews Wilson Sonsini technology transaction attorneys John McGaraghan and Andrew Poling to discuss open source software and considerations for gaming companies.
Conversation Highlights:
- an...more
Host Mary O'Brien interviews Wilson Sonsini antitrust and competition attorneys Thomas Pflock and Brendan Coffman to discuss antitrust laws and potential impact for gaming companies....more
Many video games are marketed on the photorealism of their imagery and graphics. However, depending on the depiction, developers and publishers may need to worry about the underlying intellectual property rights in that...more
Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more
In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...more
On November 17, 2020, nine months after the start of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Lucira Health for the first COVID-19 diagnostic test for...more
With the 2020 Presidential election upon us, many members of the cannabidiol (CBD) and cannabis (marijuana) product industries, as well as consumers alike, are wondering if the election will result in policy changes that...more
11/3/2020
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dispensaries ,
General Elections ,
Hemp Cultivation ,
Hemp Related Businesses ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Popular
The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...more
On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National...more
On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National Institute...more
On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs
On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the...more