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Pharmaceutical Industry › Public Health › Medical Research

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

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Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

McDermott Will & Schulte

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

McDermott Will & Schulte on

Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

Polsinelli

COVID-19 Update – Prioritized Examination Program for Certain Trademark Applications at the United States Patent and Trademark...

Polsinelli on

Recently the United States Patent and Trademark Office (USPTO) announced a new prioritized examination program for trademark and service mark applications meeting certain requirements. The program allows applicants to...more

International Lawyers Network

Compulsory Licensing in Russia in the view of COVID-19

International Lawyers Network on

Nowadays the sphere of healthcare is becoming one of the mostly discussed because of a mass spread of the coronavirus pandemic (also COVID-19). Confirmed cases of COVID-19 around the world have passed more than a 2.4 million....more

Jones Day

FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials

Jones Day on

The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses. The Development: The U.S. Food and Drug...more

Hogan Lovells

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

Hogan Lovells on

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and...more

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