Practice

Pharmaceuticals and Biotechnology Regulatory

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.

Brochures

Driving forward the next wave of medical innovation: How we can support your digital health efforts

As the industry forges ahead to advance the digital health ecosystems, the companies in this space will navigate a complex set of business and legal issues that are often evolving in...

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Hogan Lovells Publications

International Products Law Review

We are excited to bring you the latest issue of International Products Law Review with insights and updates on all aspects of products law. In this issue we explore new approaches to motor...

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Blog Post

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

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Hogan Lovells Publications

HHS announces public meeting on ways to accelerate clinical innovation Health Alert

Government seeks industry comment on expediting medical product development

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Hogan Lovells Publications

FDA's "Project Facilitate" pilot to collect metrics on sponsor expanded access denials Focus On Regulation

This morning, the U.S. Food and Drug Administration (FDA) announced it launched its new expanded access pilot called "Project Facilitate," a concierge call center under the Oncology Center...

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