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FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Key Takeaways from the 2025 JP Morgan Healthcare Conference

Several members of our firm’s life sciences team were on the ground at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13 to 16, 2025. It was an exciting and sunny four days, during which key...more

Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities...more

Blockbuster Biologics Review | Issue 25

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

How the US Election May Affect the FDA Regulation of Life Sciences Products – Key Areas to Watch

The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift...more

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration...more

FDA Issues Long-Awaited Diversity Action Plan Guidance

Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and...more

Life Sciences Post-Chevron: Navigating the Range of Legal and Regulatory Challenges Raised by Loper Bright

The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more

FDA Issues Draft Guidance on Its New Platform Technology Designation Program

Taking a step toward fulfilling its requirements under Section 506K of the Federal Food, Drug, and Cosmetic Act (Section 506K), FDA has issued Draft Guidance describing how the agency intends to implement the Platform...more

Blockbuster Biologics Review - Issue 23

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Key Issues for Life Science Executives for 2024: JP Morgan Healthcare Conference Takeaways

It is hard to believe that we are already in February and it has been a month since the 42nd Annual JP Morgan Healthcare Conference in San Francisco wrapped. It was a packed four days in which the major players in the life...more

Blockbuster Biologics Review - Issue 22

Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more

Pharma’s Almanac: Forecast at the Turn of the Year

The ball has dropped on the healthcare and life sciences industry’s unique New Year tradition, the J.P. Morgan Healthcare Conference, so all eyes turn to 2024. To help define a path forward, Morgan Lewis FDA and healthcare...more

Year in Review: How 2023 Events Affected Life Sciences Companies and Transactions

On the last day of the 2024 J.P. Morgan Healthcare Conference, we’re taking a look back at the last year to revisit the developments that had a considerable impact on the life sciences industry, including the transactional...more

2023 Drugs and Biologics Year in Review: Will FDA's 2023 Evolution Usher in Swift Resolutions for 2024?

The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more

FTC Policy Statement on Orange Book Listings Brings More Clarity (Sort Of)

With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration...more

FDA Rounds Out 2023 with Advanced Manufacturing Technologies Designation Program Guidance

As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and...more

FDA Guidance Confirms That Multiple Roads Lead to Substantial Evidence of Effectiveness

Substantial evidence, the evidentiary standard for effectiveness established in 1962 by the US Federal Food, Drug, and Cosmetic Act (FD&C Act), is the measure against which all drugs and biologics are approved in the United...more

FDA Issues Draft Guidance on Off-label Statements: A New Frontier or Acknowledgement of the Status Quo?

The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred...more

Regulatory Spotlight for Biotech: On the Horizon for CBER

FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important fronts—leadership, significant...more

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify...more

Reassessing Drug Inspection Targets: FDA Updates Internal Policy for Risk-Based Site Selection Model

In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy)....more

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