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Medical Devices › PHRMA

McDermott Will & Emery

The Tale of Two CE Programs: OIG Compares Healthcare Provider and Third-Party Continuing Education in Recent Advisory Opinion

McDermott Will & Emery on

The Office of Inspector General of the US Department of Health and Human Services (OIG) issued Advisory Opinion 22-14 (AO 22-14) on June 29, 2022, concerning continuing education (CE) programs to be offered by an...more

Goodwin

PhRMA Issues Updates to Longstanding Code, Addresses OIG’s Speaker Program Guidance

Goodwin on

PhRMA, the pharmaceutical manufacturer trade association, announced on Fri. August 6 that it has revised its longstanding Code on Interactions with Health Care Professionals. The revisions, which relate to the Code’s...more

McDermott Will & Emery

Special Fraud Alert: OIG Raises Concerns with Speaker Programs

McDermott Will & Emery on

In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more

Arnall Golden Gregory LLP

PhRMA Takes a Stance on Virtual Lunch and Learns During the Emergency Period

Arnall Golden Gregory LLP on

We received a number of questions from pharmaceutical and medical device clients over the past several months regarding how to continue “Lunch and Learn” programs for healthcare professionals during the COVID-19 pandemic....more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Patterson Belknap Webb & Tyler LLP

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

Patterson Belknap Webb & Tyler LLP on

This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more

Knobbe Martens

FDA Will Hold Hearing on Communications Regarding Unapproved Uses

Knobbe Martens on

The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on...more

Cooley LLP

Blog: FDA Announces Critical Off-Label Forum for Drugs and Devices

Cooley LLP on

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders...more

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