article thumbnail

Graduation Virtual Live Stream - February 22, 2025

Paralegal.edu

On Saturday, February 22, 2025, at 10:00 AM Central, Center for Advanced Legal Studies (CALS) will hold its 75th Commencement Ceremony for graduates of its paralegal programs. She manages all aspects of diligence and the FCPA compliance program. The commencement address will be presented by Elisa Calderon-Sierra, CFE.

article thumbnail

When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog

FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study. However, it left unanswered what underway means, noting an intention to address this authority in the now published January 2025 draft guidance.

Diligence 105
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Human rights groups urge EU to reject proposed Omnibus Directive

JURIST

The proposal , introduced by the European Commission in February 2025, aims to streamline corporate sustainability reporting and due diligence requirements. The proposal is part of a broader effort to reduce regulatory burdens on businesses and enhance the EU’s global competitiveness.

Diligence 104
article thumbnail

The ICJ’s Advisory Opinion on Climate Change: Key Takeaways from the 2024 Hearings (Part 1)

ClimateChange-ClimateLaw

ITLOS published its advisory opinion in May 2024, and the IACtHR opinion is expected later in 2025. The request happened in parallel to similar advisory opinion processes before the International Tribunal for the Law of the Seas (ITLOS) and the Inter-American Court of Human Rights (IACtHR).

article thumbnail

The New Way of Conducting Patent Research: Proven Strategies For Efficient Due Diligence

Speaker: Andrew Klein and Jennifer Vandenplas

Patent due diligence processes take too long. Join us to hear best practices in researching and producing thorough patent due diligence reports. Register now and start mastering patent due diligence like a pro! There are better methods!

article thumbnail

In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog

M&A rises and falls on due diligence along with other factors like market conditions and growth opportunities, so compliance and quality are vital links in any deal chain. For one thing, the possible answers to our rhetorical questions above are not final yet and will take years to sort out.

article thumbnail

DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

FDA Law Blog

23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. In Neumanns Pharmacy, LLC , 90 Fed.