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

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological ...

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Hogan Lovells Publications

Outlook for OTC drug regulation

Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000...

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Hogan Lovells Publications

UK M&A: Brexit and investment in UK life sciences

While Brexit is likely to result in sweeping changes to the UK’s life sciences sector, the rate of M&A and foreign investment is a positive sign that the region will uphold its...

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Published Works

China: Breaking Down the “Great Wall”?

Driven by rapid economic growth and the world’s largest rapidly aging population, China’s pharmaceutical market has become the second largest worldwide, only...

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Blog Post

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of...

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Hogan Lovells Publications

A road map to successful life sciences transactions in Europe

U.S. based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions.

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