CSC Guidance Unveiled: NIL Enforcement and Implications for Collectives — Highway to NIL Podcast
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
The NCAA's Recent Q&A Document: Clues on What NIL Enforcement Will Look Like Post-House — Highway to NIL Podcast
Understanding the Impact of IPR Estoppel and PTAB Discretionary Denials — Patents: Post-Grant Podcast
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
All Things Investigations: Navigating New DOJ Directives - Declinations, Cooperation, and Whistleblower Programs with Mike DeBernardis and Katherine Taylor
Compliance Tip of the Day: New FCPA Enforcement Memo - What Does it Say?
PODCAST: Williams Mullen's Benefits Companion - Forfeitures Under Fire
Abortion Protections Struck Down, LGBTQ Harassment Guidance Vacated, EEO-1 Reporting Opens - #WorkforceWednesday® - Employment Law This Week®
Podcast - New Guidance on Complying with FTC Rule on Deceptive and Unfair Fees
100 Days In: What Employers Need to Know - Employment Law This Week® - #WorkforceWednesday®
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
The Regulatory Situation After the Trump Executive Orders Regulatory Freeze Pending Review
A Deep Dive into HUD's New Guidance on AI-Driven Targeted Advertising — The Consumer Finance Podcast
Podcast: California Employment News - Department of Labor Guidance on Telework
California Employment News: Department of Labor Guidance on Telework
GILTI Conscience Podcast | Amount B Back in the Spotlight
The Briefing by the IP Law Blog: Copyright Office Issues Guidance for Works Containing Material Generated by AI
Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft...more
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more
Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more