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
#WorkforceWednesday: EEOC's LGBTQ+ Guidance Blocked, Employer COVID-19 Update, NYC Prepares for Pay Transparency Law - Employment Law This Week®
New DOJ Guidance Tightens Corporate Enforcement Strategy
Employment Law Now VI-119 - What Did You Miss This Summer?
#WorkforceWednesday: Updated CDC Guidance, Monkeypox Outbreak, and EEO-1 Pay Data - Employment Law This Week®
The Burr Broadcast – Labor and Employment Update
Discretionary Denials at the PTAB: What to Expect? - Patents: Post-Grant Podcast
NCAA Issues New Guidance on Name, Image and Likeness
#WorkforceWednesday: Federal Focus on Mental Health, FTC and Noncompetes, Gig Work Risks for Hospitals - Employment Law This Week®
#WorkforceWednesday: Focus on Caregiver Discrimination, Harassment and Discrimination Protections in NY, Wage and Hour Budget - Employment Law This Week®
Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 2) - Diagnosing Health Care
Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 1) - Diagnosing Health Care
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
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
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
Artificial intelligence and machine learning are transforming the medical device industry. Simultaneously, companies are working to gain Food and Drug Administration approval and obtain intellectual property protection for...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
On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...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
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
Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more
The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials...more