Practice

Pharmaceutical and Biotechnology Regulatory Law

Drug companies face pressure from many directions — from a foreboding regulatory landscape, from competitors with alternative brands or generics, from insurers pushing back on prescription ...

Representative experience

Convinced FDA to give 5-year exclusivity to fixed dose combination products that include a new chemical entity and a previously approved active ingredient.

Successfully sued FDA to overturn denial of orphan drug exclusivity.

Wrote successful petition seeking denial of “A” rating to purported generic products.

Help respond to FDA Form 483 observations, warning letter to close out FDA investigation.

Negotiate settlement of FDA lawsuit alleging cGMP noncompliance.

Conduct internal investigation of promotional practices and help develop and implement enhanced practices.

Develop SOPs for compliant promotional activities.

Develop and negotiate with FDA over the elements of a REMS.

Represent reference product sponsor in shared REMS negotiations with generics.

Audit clinical trial study reports to ensure compliance with adverse event reporting obligations.

Counsel client on labeling changes proposed in response to emerging safety signals.

Help develop product approval strategy.

Help draft FDA meeting requests, briefing packages.

Advise client on standards for interchangeability of biosimilars.

Advise on FDA/DEA interplay during drug development and approval process, scheduling under CSA.

Conduct due diligence of FDA and EU regulatory law for IPO.

Advise private equity firm on FDA regulatory aspects of potential investments.

Hogan Lovells Publications

Podcast series: False Claims Act 2018 and the road ahead Podcast

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA...

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Hogan Lovells Publications

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data sharing plan Pharmaceutical and Biotechnology Alert

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 ...

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Webinar

The impact of Brexit on the pharmaceutical and medical device industries

Our European Life Sciences Regulatory team has been examining the potential consequences of Brexit for the pharmaceutical and medical device industries since before the results of the...

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Hogan Lovells Publications

Would you like an extra application with that? FDA mulls requiring dual applications for combination products Focus On Regulation

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...

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Hogan Lovells Publications

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...

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