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Software › Pharmaceutical Industry › Manufacturers

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Wilson Sonsini Goodrich & Rosati

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

Wilson Sonsini Goodrich & Rosati on

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

Knobbe Martens

AI & the FDA

Knobbe Martens on

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Ankura

Pharma Companies Can Ensure Data Integrity With User Access Management (UAM)

Ankura on

Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more

Hogan Lovells

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software...

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On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

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This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

Hogan Lovells

USTR Requests Input on Impact of Trade Agreements on Government Procurement

Hogan Lovells on

On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade...more

Hogan Lovells

International Product Liability Review - Issue 65

Hogan Lovells on

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more

Hogan Lovells

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

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On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2015

Akin Gump Strauss Hauer & Feld LLP on

Welcome to the August 2015 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange...more

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