About Michael C. Zogby

Michael C. Zogby co-chairs the firm’s Products Liability and Mass Tort Group and the Pharma and Life Sciences Group. Mike is a trial lawyer who handles a variety of complex, aggregate litigation, including products liability, medical device, life sciences, class action, consumer disputes, intellectual property, trade secrets, toxic tort, multidistrict proceedings, and data collection and privacy inside and outside the United States. Read Mike's full bio

FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts on how sponsors can comply with the Federal Food, Drug and Cosmetic Act (FDCA) when submitting “certain” applications that contain study data derived from real-world data (RWD) sources. The FDA acknowledges that its current study data standards do not necessarily reflect a process derived from RWD sources. However, sponsors will need to convert RWD into established study data standards when submitting this information as part of a regulatory application (a process called “mapping”).

For context, study data standards are documented guidelines to help with the exchange of clinical and nonclinical study data between computer systems. They are used to provide a consistent framework for organizing study data (such as templates for datasets, standard names for variables, how to do calculations with common variables, and so on).

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FDA Posts Draft Guidance for Pharma Companies, Sponsors, and Researchers on Using Real-World Data from Health Records in Clinical Studies

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define guidelines on sourcing RWD, the draft document provides insight into the FDA’s current thinking on the approach that companies should use to support regulatory filings for medications.

The guidance references the Framework for Real World Evidence Program, released in December 2018. The Framework is designed to regulate uses of RWD and Real Word Evidence (RWE), which are used by life sciences companies to investigate how medicines perform beyond clinical trials, and to back up clinical trial results. This draft guidance is the first of the series that have been promised by the FDA to develop the Framework. More information about the FDA Framework can be found on our blog here.

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FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.

The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.

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District of New Jersey Clarifies New Local Civil Rule Regarding Third-Party Funding Disclosures

Over the last four months, we have tracked the District of New Jersey’s proposal and adoption of a new Local Civil Rule – L. Civ. R. 7.1.1 –  requiring lawyers to disclose details about third-party litigation funding.  The Clerk of the District of New Jersey has now issued a Notice to the Bar clarifying that this new Rule only requires the filing of a statement where third-party litigation funding exists.

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New Jersey Ethics Committee: Beware Marketers that “Lead” to Ethics Violations

Increasingly popular online “lead generation” services offering to connect attorneys with potential mass tort plaintiffs may expose counsel to ethics violations, the New Jersey Advisory Committee on Professional Conduct cautioned in two recent advisory opinions.

New Jersey attorneys are charged with the affirmative responsibility to “question whether the marketing company is improperly labeling its services,” the committee stated in a June 21, 2021 joint opinion with the Committee on Attorney Advertising.  On the same date, the Advisory Committee issued another joint opinion with the Committee on the Unauthorized Practice of Law offering further insight on the circumstances in which a permissible client lead becomes an improper for-profit referral.

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District of New Jersey Adopts Local Civil Rule Requiring Disclosure of Third-Party Litigation Funding

The U.S. District Court for the District of New Jersey has adopted new Local Civil Rule 7.1.1, requiring lawyers to disclose details about third-party litigation funding.  On June 21, 2021, Chief Judge Freda L. Wolfson signed the order formally amending the Rule to include Section 7.1.1.

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