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Food and Drug Administration (FDA) Big Data

Morgan Lewis

The Next Big Things: Insights for 2020

Morgan Lewis on

Autonomous cars, sports betting, and CBD products have burst onto the scene, setting the stage for major developments in how companies do business and how regulators monitor new innovations....more

McDermott Will & Emery

US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

McDermott Will & Emery on

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more

McDermott Will & Emery

US Office of Management and Budget Issues a Memorandum Calling for Agency Plans From Federal Government Agencies

McDermott Will & Emery on

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Foley & Lardner LLP

Manufacturing MarketTrends - July 2019, Issue 2

Foley & Lardner LLP on

Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more

Troutman Pepper

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

Troutman Pepper on

A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more

Troutman Pepper

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

Troutman Pepper on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Manatt, Phelps & Phillips, LLP

Health Update - January 2017

Top Five Healthcare Antitrust Trends to Watch in 2017 - Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

McDermott Will & Emery

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

McDermott Will & Emery on

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel...more

Foley & Lardner LLP

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

Foley & Lardner LLP on

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

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