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Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

Akin Gump Strauss Hauer & Feld LLP on

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Cadwalader, Wickersham & Taft LLP

European Supervisory Authorities Make Recommendations for the EU Securitisation Market

Cadwalader, Wickersham & Taft LLP on

Background Article 44 of the EU’s Securitisation Regulation (“SECR”) requires the Joint Committee of the European Supervisory Authorities (“ESAs”) to produce a report every three years on: (a) the implementation of...more

Kohrman Jackson & Krantz LLP

OTC Markets Launches New Market Tier: OTC Pink Companies Must Act Now to Avoid Downgrade

Kohrman Jackson & Krantz LLP on

Starting July 1, 2025, the OTC Markets Group will introduce OTCID Basic Market, replacing the current Pink Current tier. The OTC believes that this change will enhance transparency and provide investors with clearer insights...more

DarrowEverett LLP

Fifth Circuit Puts the Brakes on SEC’s Private Fund Rules: What’s Next For Private Fund Advisers

DarrowEverett LLP on

In a continuation of recent court decisions overturning the rulemaking authority of federal agencies, a recent decision by the U.S. Court of Appeals for the Fifth Circuit vacated the Securities and Exchange Commission’s (SEC)...more

Thomas Fox - Compliance Evangelist

Boeing: Accept the Omnibus Monitor Approach

Thomas Fox - Compliance Evangelist on

I recently wrote a series of blog posts and articles on why the Department of Justice (DOJ) should think big and go big with a completely new approach to the monitorship for Boeing under its agreement to take a guilty plea....more

White & Case LLP

SEC Adopts Final Private Fund Adviser Rules

White & Case LLP on

New rules are expected to have substantial impact on funds industry - On August 23, 2023, the Securities and Exchange Commission ("SEC") approved significant new rules applicable to advisers of private funds (the "Private...more

Sullivan & Worcester

SEC Adopts Highly Anticipated Private Funds Rules

Sullivan & Worcester on

The U.S. Securities and Exchange Commission (the “SEC”) last week adopted highly anticipated new rules and amendments (the “Adopted Rules”) to the Investment Advisers Act of 1940, as amended (the “Advisers Act”), that will...more

DarrowEverett LLP

What SEC’s Transparency Rule Means for Investors, Advisers and Funds

DarrowEverett LLP on

Earlier this summer, we wrote about both new and amended rules proposed by the Securities and Exchange Commission (“SEC”) under the Investment Advisers Act of 1940 (the “Advisers Act”) regarding private funds, their advisers,...more

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