News & Analysis as of

Securities and Exchange Commission (SEC) Food and Drug Administration (FDA)

Morgan Lewis - As Prescribed

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

Benesch

AI Reporter - June 2025

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The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...more

Paul Hastings LLP

Biotech Spin-Off Transactions

Paul Hastings LLP on

As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more

McDermott Will & Emery

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

McDermott Will & Emery on

Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more

Morgan Lewis - As Prescribed

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

Fenwick & West LLP

Clinical Data FAQs: How to Prepare for Disclosure

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When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more

BCLP

Medical Device Company Settles Fraud Charges With SEC, Agrees to Pay $175m Civil Penalty and Retain Compliance Consultant

BCLP on

On December 16, 2024, the SEC announced settled charges against Becton, Dickinson and Company for misleading investors about risks associated with its continued sales of one of its key products and overstating its income by...more

Cooley LLP

SEC charges Becton Dickinson with misleading investors about regulatory risks and product sales

Cooley LLP on

The SEC has announced settled charges against Becton, Dickinson and Company, a medical device manufacturer known as BD listed on the NYSE, for “repeatedly misleading investors about risks associated with its continued sales...more

Stinson LLP

Trump's First 100 Days: Business Litigation

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Banks and other regulated entities have frequently challenged Biden-era rulemakings in court. The incoming administration may change the trajectory of these cases, as Trump has promised to stop agency overreach....more

McDermott Will & Emery

Post-Chevron Insights and Resources

McDermott Will & Emery on

On June 28, 2024, in Loper Bright Enterprises v. Raimondo, the US Supreme Court overruled the decades-old Chevron doctrine. This decision means that courts must now determine the meaning of federal statutes and effectively...more

Cozen O'Connor

Cozen Currents: The CEO's Guide to Trump 2.0

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“CEOs tended to take a wait and see approach at the start of the first Trump administration. But it would be a mistake not to engage early and often with Trump 2.0.” — Howard Schweitzer, CEO, Cozen O’Connor Public Strategies...more

Mintz - ML Strategies

2024 Post-Election Analysis

Mintz - ML Strategies on

Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more

DLA Piper

Food and Beverage News and Trends - September 2024 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

BCLP

Selected Recent Developments for Public Companies

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Public companies should take note of several recent developments, including: ..Reversal of the Pegasystems trade secrets lawsuit that nevertheless preserves guidance to take care when describing litigation as “without...more

Fenwick & West LLP

Disclosure Trend: Risk Factors Post-Chevron

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Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more

Akin Gump Strauss Hauer & Feld LLP

The Top 10 Takeaways for Businesses from the Supreme Court’s Three Big Administrative Law Decisions in 2024

Now that the dust has settled following the Supreme Court’s overhaul of administrative law through three late-term decisions, Akin litigators and policy advisors offer the most significant takeaways for businesses and...more

Cozen O'Connor

The State AG Report – 7.18.2024

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Gasoline Trading Firms to Pay $50 Million to Settle...more

Beveridge & Diamond PC

Has the major questions doctrine had a major impact?

Since its formal announcement as a constitutional “doctrine” in West Virginia v. EPA, administrative and environmental law practitioners have speculated that the major questions doctrine (MQD) would mark a major shift in how...more

Mintz - Securities Litigation Viewpoints

Supreme Court in Jarkesy Limits the SEC’s Powers to Use In-House Administrative Courts

On June 27, the Supreme Court issued its decision in the closely-watched SEC v. Jarkesy, holding that the SEC could no longer seek civil monetary penalties for fraud in its in-house courts consistent with the Seventh...more

Skadden, Arps, Slate, Meagher & Flom LLP

Insights – June 2024

Explore the unique considerations for mergers and acquisitions in the AI sector, the return of IPOs, the implications of new Supreme Court decisions and other developments in this edition of Skadden’s quarterly Insights....more

NAVEX

A Look at the Whistleblowers Who Made Lasting Impacts

NAVEX on

As seen in the previous article, whistleblowing cases regularly make the news headlines. And while some of the names of the reporters or the cases are well known, it’s worthwhile to take a closer look at the people behind the...more

ArentFox Schiff

Four Months Out: Private Fund Advisors Prepare for September Compliance Deadline Amidst Challenge in the Fifth Circuit

ArentFox Schiff on

In September 2023, we covered the Rules (Rule) published by the US Securities and Exchange Commission (SEC), developed to promote transparency for investors by increasing visibility into compensation schemes, sales practices,...more

Wiley Rein LLP

CISA’s Proposed Cyber Incident Reporting Requirements Would Hit a Range of Industries and Sectors

Wiley Rein LLP on

The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Cozen O'Connor

The State AG Report – 2.22.2024

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •FTC, California DFPI Team Up Against Mortgage Relief Scams...more

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