Legal Use Case 7: A Conversation
Legal Use Case 7 Part II: The Prescription
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
We have previously written an OnPoint about the law concerning ownership of social media accounts in light of the explosive growth in the use of such media for commercial advertising, product development and customer...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more
Cooley’s AI Talks series highlights multidisciplinary perspectives on artificial intelligence and showcases the firm’s subject matter knowledge on the intricacies – and complexities – of large language models, machine...more
On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more
When it comes to product development, the management of third-party intellectual property (IP) to ensure freedom to operate is of paramount importance. Drug development is no different. Imagine investing years of research,...more
The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this integration can require...more
This month we are excited to feature AeroShield Materials, a manufacturer of super-insulating materials to decarbonize the world’s built environment. Last month AeroShield Materials announced the closing of its Seed funding...more
What is an “NNN” agreement and why might you want to use one? “NNN” stands for “Non-Disclosure/Non-Use/Non-Circumvention.” An NDA is just a non-disclosure agreement (which often also includes a non-use clause) that’s designed...more
The US Office of the Comptroller of the Currency (OCC), a primary US banking regulator, has recently published its Model Risk Management (MRM) Handbook. It details how the OCC expects its chartered banks to manage their MRM...more
Adam Bahret of Apex Ridge Reliability defines Use Case 7 as the way a customer may use your product in a manner that is way beyond anything you expect. Product engineers may explore Use Case 7 to reveal weaknesses in a...more
In the second installment of the Legal Use Case 7 series, White and Williams lawyers Frank Bruno, Jim Burger and Bill Kennedy expand upon their first conversation with Apex Ridge Reliability engineer and originator of the Use...more
The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it did in the draft version that “application-based...more
When a company desires to develop technology, it has two options: develop the technology in-house by its employees, or contract with a third-party developer to develop the technology. ...more
This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more
The quality, taste, and appearance of food and beverage products are important, but there are other aspects of those products that also contribute to, and even sustain, their commercial success. In particular, the...more
As the workforce shifts to remote working environments, it is critical that companies continue to smartly build their patent strategy despite drastically reorganized workflows. With more than 80% of a company’s value tied to...more
Welcome to Day 7! Before we talk about how you should run your business, I want to give you a view of how I ran mine. Hopefully this transparency is helpful. Learning From Business - We know they don’t teach us much...more
Government seeks industry comment on expediting medical product development - The U.S. Department of Health and Human Services' (HHS) Immediate Office of the Secretary (IOS) has announced it will hold a public meeting...more
The impact of artificial intelligence, or more specifically machine learning, is being felt in every industry sector, but perhaps nowhere more so than in healthcare, where AI funding hit historic highs in 2018, according to...more
June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more
When companies make products that are not safe, they automatically increase their liabilities. This is not in anyone’s interest. Costs increase. Bad PR increases. Good will is lost. Insurance rates go up. And, most...more
Manufacturers continue to look for ways to increase sales revenue without a massive infusion of capital. Many companies have been successful in adapting current products for new uses and markets. For instance, a company...more
I used to jokingly tell people that when I moved from design engineering into the law I went from the most productive field in the world to the most counter-productive field. This joke plays on the common misconception that...more
Hard to believe that more than 11 years have transpired since my partner-boss Press Millen (known for his perpetual perch on the leading edge) and I distributed a memo encouraging lawyers to help us develop legal products....more
On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. The proposed rule would require that...more