News & Analysis as of

Pharmaceutical Industry Strategic Enforcement Plan

Hogan Lovells

FDA releases enforcement policy for VTM and PBS/saline transport media during the COVID-19 pandemic

Hogan Lovells on

On July 21, 2020, the U.S. Food and Drug Administration (FDA) issued an immediately in effect enforcement policy guidance to help facilitate the availability of devices used in transporting clinical specimens for the duration...more

Troutman Pepper

How to Prepare for the FDA's 2019 Enforcement Priorities for the Compounding Industry

Troutman Pepper on

On April 3, FDA Commissioner Scott Gottlieb released a statement outlining the agency’s priorities for 2019 with respect to compounding pharmacies and the compounding industry. ...more

Wilson Sonsini Goodrich & Rosati

Update on the DOJ's Criminal Investigation into Generic Pharmaceuticals

The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more

Mintz - Securities & Capital Markets...

SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies

In a wide-ranging speech on Tuesday, Securities and Exchange Commission Director of Enforcement Andrew Ceresney discussed recent SEC actions and current concerns involving the pharmaceutical and medical technology industries....more

Skadden, Arps, Slate, Meagher & Flom LLP

"Insights Conversations: Life Sciences"

A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more

The Volkov Law Group

Criminal Global Cartel Focus on Generic Pharmaceuticals

The Volkov Law Group on

The Antitrust Division is nearing the end of its largest, record-setting criminal cartel investigation – global auto parts suppliers. It has been a sprawling investigation that has leaped from product-to-product in the auto...more

Blank Rome LLP

Court Decisions in the U.S. and China Bolster Law Enforcement’s Ability to Prosecute Global Corporate Corruption

Blank Rome LLP on

On October 6, 2014, the United States Supreme Court declined to accept an appeal involving violations of the Foreign Corrupt Practices Act (“FCPA”)—the U.S. statute that criminalizes the bribing of foreign officials. The...more

Carlton Fields

Expect Focus - Regulators Are Watching: New Products, New Opportunities, New Risks - Volume III, Summer 2014

Carlton Fields on

In This Issue: - IN THE SPOTLIGHT ..Standard CGL Policy Form Adds Data Breach Coverage Exclusion - LIFE INSURANCE ..Class Claims Against Lincoln National Barred in Section 419 Action – Again ...more

McDermott Will & Emery

New IP Enforcement Policy in the EU

McDermott Will & Emery on

Given that strategic importance of IP-sensitive industries for the EU economy, the European Commission (Commission) has introduced a new initiative with a view to strengthen the protection of EU-based IP rights by working...more

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