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Clinical Trials › Regulatory Oversight › Biologics

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

McDermott Will & Schulte on

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Guidance on Drug and Biologic Submissions with Real-World Data and Real-World Evidence

Wilson Sonsini Goodrich & Rosati on

Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Draft Guidance for Sponsors and Other Stakeholders on Using Registries as RWD to Support Regulatory Decision-Making

Faegre Drinker Biddle & Reath LLP on

The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more

Faegre Drinker Biddle & Reath LLP

FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

Faegre Drinker Biddle & Reath LLP on

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more

Morgan Lewis - As Prescribed

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

American Conference Institute (ACI) on

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...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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