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Life Sciences › Pharmaceutical Industry › Scientific Research

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

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In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

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The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

McDermott Will & Schulte

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

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On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Epstein Becker & Green

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

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On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more

Vicente LLP

What is the Process for Federal Psilocybin Registration?

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We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more

Health Care Compliance Association (HCCA)

Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

Health Care Compliance Association (HCCA) on

Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more

Hogan Lovells

Anti-benefits regulations: the last piece of the regulatory puzzle published

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Decree no. 2020-730 of 15 June 2020 and the ministerial orders of 7 August 2020 have completed and specified the new anti-benefits regulations which will come into force on 1 October 2020...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 9. In This Month's E-News: September 2020

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Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more

Hogan Lovells

HHS now requires public posting of a decade of clinical trial results that were previously exempted

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Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more

Goodwin

Researchers Publish Results Of Biosimilar-Switching Studies

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In 2017, the Health Department of Brazil’s Federal District ordered that patients currently prescribed Remicade (infliximab) be switched over to the biosimilar, Remsima.  Earlier this month, researchers in Brazil published a...more

Hogan Lovells

The new Belgian Biobank legislation will apply on 1 November 2018: are you ready?

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The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human...more

Troutman Pepper Locke

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

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Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

Goodwin

FDA Issues Draft Guidances on Targeted Therapies and the Use of Standards

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The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions...more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders

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This is the first installment in a series on advancements in microbiome research and development. Our goal with this series is to inform readers about developments in this important and growing field and to highlight, where...more

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