Mahnu Davar

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A new report commissioned by Arnold & Porter, based on a survey of 100 senior executives and department heads from biopharmaceutical, digital health, diagnostics, and medical device companies, shows that artificial intelligence (AI) adoption is accelerating across the industry as companies implement it to accelerate product discovery and development, optimize manufacturing and the supply chain, improve marketing and sales strategies, and more.

However, as with any disruptive innovation, risks need to be managed. The report also highlights looming governance and compliance needs as companies seek to mitigate the risks associated with AI technologies, particularly in areas like data privacy, cybersecurity, and intellectual property.

The Arnold & Porter report found that AI use is still in its early stages for many in the life sciences industry, with around 75% of respondents beginning implementation less than two years ago. Despite this, 86% of companies currently integrating AI plan to fully deploy these tools within the next two years, reflecting a significant acceleration in AI adoption.Continue Reading The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk

On 6 May 2024, the U.S. Food and Drug Administration (FDA) published its highly anticipated final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs).

Historically, FDA exercised enforcement discretion for LDTs, declining to impose its device authority over such tests in most instances. Under the new final rule, LDT manufacturers that generally operated outside FDA oversight will now be expected to come into compliance with FDA requirements and controls applicable to their tests. In consideration of this substantial operational and compliance burden, the preamble to the final rule details a phaseout policy under which FDA will gradually end its general LDT enforcement discretion policy in five phases over a four-year period, as follows:Continue Reading What you need to know about the FDA Laboratory Developed Test Final Rule

On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation, which sets out the FDA’s quality management system (QMS) requirements for medical devices. The amendments seek to align more closely with International Standard Organization (ISO) standard 13485:2016, Medical Devices —…

On 22 February 2022, the U.S. Food and Drug Administration (FDA or the Agency) announced that it was issuing a proposed rule to align the Agency’s current Good Manufacturing Practice (GMP) requirements for medical devices, codified at 21 C.F.R. Part 820 and known as the Quality System Regulation, with the international consensus standard ISO 13485:2016 (the ISO). This reflects a years-long effort by the Agency to better harmonise the U.S. requirements with that of many foreign regulators. For example, in the European Union, the ISO is listed in the EU legislation, meaning that a medical device that conforms to this standard is presumed to be in conformity with the EU regulatory requirements on quality management systems for medical devices. This harmonisation should, therefore, provide some consistency between jurisdictions and enable companies to streamline their processes between countries.
Continue Reading Harmonisation of international rules on medical device quality management systems

In May 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance (Draft Guidance) addressing the requirement for all investigators involved in clinical trials conducted under a U.S. Investigational New Drug (IND) application to sign Form FDA 1572. This includes investigators in clinical trial sites outside the U.S.

By signing Form FDA 1572 (Form 1572), the investigator of a drug or biologic trial warrants that they and any listed staff have the experience and background needed to conduct the trial and agrees to comply with the protocol and all applicable U.S. regulatory provisions governing the conduct of clinical trials.  From an FDA standpoint, it provides a clear basis of responsibility (and potential liability) under the applicable clinical trial regulations (21 CFR 312) for those who sign the form.  It also raises questions about the extent of FDA’s extraterritorial reach over non-U.S. investigators who conduct IND studies outside of the United States.Continue Reading FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US