News & Analysis as of

Clinical Trials Pharmaceutical Industry Disclosure Requirements

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

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

Arnall Golden Gregory LLP

Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more

Fenwick & West LLP

Clinical Data FAQs: How to Approach Fundraising and Investor Relations

Fenwick & West LLP on

For publicly traded biotech companies, disclosing clinical trial data can be an exciting milestone as you build towards an exit or public offering—but disclosure is a double-edged sword....more

Fenwick & West LLP

Clinical Data FAQs: How to Prepare for Disclosure

Fenwick & West LLP on

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

Arnall Golden Gregory LLP

Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Orrick, Herrington & Sutcliffe LLP

Managing and Maintaining Clinical Trial Disclosure for Publicly Traded Life Sciences Companies

One of the fastest ways to garner unwanted attention as a publicly-traded life sciences company is to be accused by either a regulator or stockholder that the company disclosed materially misleading information about the...more

Orrick, Herrington & Sutcliffe LLP

What's New in Corporate Governance and Securities Law - October 18, 2019

Corporate Governance and Securities Law Developments - Directors Can Be Held Liable for Failure to Oversee “Mission Critical” Regulatory Compliance - On October 1, the Delaware Court of Chancery refused to dismiss a...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

Hogan Lovells on

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." ...more

Smart & Biggar

Rx IP Update - July 2018

Smart & Biggar on

IN THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more

Hogan Lovells

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

Hogan Lovells on

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures...more

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

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