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

Pharma companies may benefit from proposed patent law changes in China; public comment invited Focus On Regulation

On 4 January, China's National People's Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to...

Quick view Full view

Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Cell and Gene Therapies

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars.

Quick view Full view

Hogan Lovells Publications

President signs 2018 Farm Bill with hemp reforms – implications for regulatory oversight of hemp-derived products including cannabidiol (CBD) Pharmaceutical and Biotechnology Alert

On December 20, 2018, President Donald Trump signed the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) into law.

Quick view Full view

Media Mention

Sources: CBO Score Of OTC Monograph Could Be Sign Of Movement Inside Health Policy

David Horowitz discussed the Congressional Budget Office's (CBO) score of the U.S. Senate's over-the-counter monograph reform bill in the Inside Health Policy article titled "Sources: CBO...

Quick view Full view
Loading data