Disclosure Requirements, Life Sciences, Regulatory Requirements

Will Colorado’s Historic AI Law Go Live in 2026? Its Fate Hangs in the Balance in 2025

Epstein Becker & Green on 5/13/2025

On May 17, 2024, Colorado Governor Jared Polis signed Colorado’s historic artificial intelligence (AI) consumer protection bill, SB 24-205, colloquially known as “Colorado’s AI Act” (“CAIA”), into law....more

3 Tips for Avoiding Having to File a Budapest Treaty Declaration When Prosecuting Patent Applications on Biological Materials

Rothwell, Figg, Ernst & Manbeck, P.C. on 4/30/2025

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more

Protecting Trade Secrets in FDA Submissions from FOIA Disclosure in the Wake of FDA Layoffs

Ropes & Gray LLP on 4/8/2025

In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more

Warning - Transaction Delays Expected. State Notice Requirements Ahead for Health Care M&A!

Epstein Becker & Green on 12/1/2023

An increasing number of states are requiring advance notice of health care transactions. These requirements may delay transactions or result in confidential information becoming accessible to the public. Effective August 1,...more

COVID-19 Disclosures Bring Risks For Life Sciences Cos.

Ballard Spahr LLP on 4/22/2020

COVID-19 has upended every corner of the financial markets, including the disclosure regime for publicly traded companies. Over the last few weeks, the number of disclosures relating to COVID-19 has exploded, with as many...more

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Hogan Lovells on 2/14/2019

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more

U.S. Senate passes bill requiring prescription drug ads to include prices

Hogan Lovells on 8/29/2018

On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more

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