Topic Archives: Regulatory

September 19, 2019 - AI + Robotics, Data Analytics, FDA, Pharma, Product Liability + Class Action, Regulatory, United States

Artificial Intelligence and Pharma

By: Bethany J. Hills

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. …›

August 28, 2019 - AI + Robotics, Data Analytics, Intellectual Property, Regulatory, United States

AI Patent Policy – Calling all Life Sciences Practitioners

By: Amanda Elisabeth Casale, Anna Yuan, and Karen G Potter

In the life sciences, artificial intelligence (AI) may be facilitating a sea change in how diseases are diagnosed, prognosed, and treated, and even how therapies are discovered and produced. Indeed, it is possible for AI to provide insights into disease and treatment that could …›

July 23, 2019 - Asia, Biotech, Intellectual Property, Pharma, Regulatory

China’s new administrative regulations on human genetic resources as applied to foreign persons

By: Can Cui

The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into effect on July 1, 2019, superseding prior regulations on China’s human genetic resources (“China HGR”), particularly the 1998 Interim Methods of Human …›

July 19, 2019 - Biotech, European Union, Intellectual Property, Pharma, Regulatory

Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

By: Wolfgang Schönig

In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public. The Court of Justice of the European Union (“CJEU”) ruled in …›

July 2, 2019 - Medical Devices + Diagnostics, Product Liability + Class Action, Regulatory

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

By: Erin M. Bosman, Bethany J. Hills, and Julie Y. Park

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) …›

May 30, 2019 - Intellectual Property, Medical Devices + Diagnostics, Regulatory, United States

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

By: Rachel A. Rice and Karen G Potter

While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision …›