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FDA Releases Final Guidance on Considerations for the Use of Real-World Data and Real-World Evidence

The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties. On August 31, 2023, the US Food and Drug Administration (FDA or...more

FDA to Address Proposed Rule to Subject Laboratory Developed Tests to Agency Oversight in Public Webinar

FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach. On October 31,...more

Due Diligence: The Key Ingredient in Restaurant M&A

Due diligence on restaurant companies should factor in industry-specific legal and operational risks. Buyers acquire restaurant companies to access new brands, expand and diversify, or vertically integrate. Attractive...more

The Reproductive Sector - Fertile Ground for PE Deals

The fertility sector is likely to present growing opportunities for PE as an emerging, multifaceted industry. The global fertility sector, which has grown significantly in recent years as demand continues to soar, is...more

Cannabis Rethink Sparks PE Interest

The once shunned cannabis sector now offers attractive PE opportunities in many jurisdictions. In years gone by, the prospect of significant PE investment in the cannabis industry would have been unthinkable for many....more

Legalization of Products Containing CBD? Not Quite Yet, Says FDA

The Agency plays a significant role in the evolving legal landscape governing certain cannabis-derived products. Key Points: ..New law lifts or eases some, but not all, federal obstacles for certain cannabis-derived...more

FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual user...more

FDA Issues Draft Guidance on Biosimilar Interchangeability

Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” - On January 18, 2017, the US Food and Drug Administration (FDA or...more

FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages

Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action. The US Food and Drug Administration (FDA or...more

The Regulation of Follow-on Biologics

What is new in the world of follow-on biologics? Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more

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