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.

Blog Post

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful...

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Blog Post

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care...

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Hogan Lovells Publications

A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing Pharmaceutical and Biotechnology Alert

Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, M.D., recently indicated that the Food and Drug Administration (FDA) is unlikely to take enforcement action against a ...

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Hogan Lovells Publications

FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions Pharmaceuticals and Biotechnology Alert

On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

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Hogan Lovells Publications

New anti-kickback prohibition in opioid bill creates tangled web of compliance obligations Pharmaceutical and Biotechnology Alert

On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT...

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Hogan Lovells Publications

FDA schedules public hearing on solutions to drug shortages Pharmaceuticals and Biotechnology Alert

The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers,...

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