News & Analysis as of

Pharmaceutical Industry The United States Food and Drug Administration Clinical Trials

FDA Simplifies and Clarifies Expanded Access Program

by Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

by Hogan Lovells on

On September 12, 2017, the U.S. Food and Drug Administration (FDA) released the final guidance that outlines the agency’s expectations and recommendations for the evaluation and reporting of age-, race-, and...more

Sandoz Announces New Data For Its Adalimumab Biosimilar

by Goodwin on

Last week, Sandoz announced new data reportedly showing that its proposed adalimumab biosimilar matches the safety and efficacy profile of Humira®. The data was obtained from a long term study of patients with...more

How Not To Create an “Exception” to the Learned Intermediary Rule

by Reed Smith on

We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers. But while it’s illegal for anybody working for the U.S. government to accept...more

FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research

by Ropes & Gray LLP on

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirements for an FDA-regulated clinical...more

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

by 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

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Glenmark Pharmaceuticals Begins Clinical Investigation for Omalizumab Biosimilar

by Goodwin on

In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

by Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

Six Key Changes to the Common Rule

by Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

FDA Issues New Guidance on Use of Clinical Pharmacology Studies to Show Biosimilarity

by Goodwin on

The FDA issued a new Guidance today, titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The Guidance is intended to “assist sponsors with the design and use of clinical...more

21st Century Cures Act Becomes Law

On December 13, 2016, President Obama signed the 21st Century Cures Act (H.R. 34) into law. The act's 312 pages contain a variety of provisions, including nearly $5 billion in funding for scientific research, $1 billion in...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

by Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

by Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart

by DLA Piper on

Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations...more

Sandoz: Etanercept biosimilar switch has no impact on safety and efficacy

by Goodwin on

Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved...more

Ninth Circuit Smells a Rat and Reinstates Claim That Pharmaceutical Company Failed to Disclose Cancers in Animal Testing

The Ninth Circuit recently revived a securities class action against Arena Pharmaceuticals, issuing a decision with important guidance to pharmaceutical companies speaking publicly about future prospects for FDA approval of...more

New Clinical Trial Rule Alters Reporting Requirements

by Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

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

by 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

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

by Reed Smith on

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on...more

FDA's 'Active Moiety' Interpretation of the Three-Year Clinical Investigation Exclusivity

by Pepper Hamilton LLP on

The court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity. In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District of...more

Dual Tracks Taken by FDA in Approving Products by ‘Big Pharma’

Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration has the responsibility to...more

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