The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties.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 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 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
8/17/2022
/ Acquisitions ,
Business Licenses ,
Contract Terms ,
Cybersecurity ,
Due Diligence ,
Environmental Social & Governance (ESG) ,
Food Safety ,
Franchise Agreements ,
Franchises ,
Liquor Licences ,
Mergers ,
Restaurant Industry ,
Suppliers ,
Wage and Hour
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
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
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
5/9/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Comment Period ,
Controlled Substances Act ,
Enforcement Authority ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Public Hearing
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
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
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
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
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