News & Analysis as of May 20, 2025

Biologics

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DE Under 3: OFCCP Resurrects Proposal for Monthly CC-257 Employment Utilization Reports for Construction Contractors
The NYDFS Updates Its Stringent Cybersecurity Regulations. Is This a Bellwether of Coming Industry Change? - The Consumer Finance Podcast
Non-Compete Agreements: An Endangered Species?
DE Under 3: Behind the Scenes of EEOC’s Full Commission Hearing
DE Under 3: Data Gathering & Data Delivery
Kilptrick Townsend Digital Assets Minute | U.S. Treasury—Comments on Digital Assets Development Due August 8th
DE Under 3: Updated EEOC COVID-19 Technical Assistance Guidance, Case Decision & Wage & Hour Division Proposed Rule
CA DFPI Request for Comment on Cryptocurrency-Related Financial Products and Services - The Consumer Finance Podcast
DE Under 3: New Data Collection Burdens, NLRB’s Ruling Regarding Union Election Dismissals, and OMB’s Tech Modernization Fund
Digital Assets Regulation Framework: Commerce Solicits Public Comment
DE Under 3: EEOC & DOJ Technical Guidance for Employer’s AI Use; Upcoming EEOC Hearing; Event for Mental Health in the Workplace
Comment Deadline Approaching: Proposed Amendments Restricting Use of Prop 65 Short-Form Warnings
DE Under 3: OFCCP Contractor Portal & Request for Comments for Functional Affirmative Action Programs (FAAPs)
2BInformed: The Future of Fluoride in Drinking Water, the New TSCA Fees Rule, and the Drinking Water Contaminant Candidate List 5
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Recent Actions on Ag Biotech by EPA’s Emerging Technologies Branch
Podcast: Private Fund Regulatory Update: Post-U.S. Government Shutdown
III-42-The New Overtime Rule and Antitrust Issues With Your Non-Competes
[WEBINAR] Laying the Foundation for Maximizing Benefits Around Emerging Technologies
[WEBINAR] Fairly (or Unfairly?) Traceable: Are Discharges Through Groundwater Subject to the Clean Water Act?

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 1/15/2025

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

K&L Gates LLP on 6/1/2023

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more

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Public Comment › Regulatory Requirements › Biologics

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

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