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
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more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
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
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
As 2023 came to a close, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated General Compliance Program Guidance (GCPG) manual, which serves as a reference guide for...more
On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more
On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more
On April 7, 2023, two federal judges in Texas and Washington State issued dueling opinions about the abortion medication Mifepristone, just hours apart. These two decisions come in the midst of growing tension about abortion...more
With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more
Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more
On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more