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

Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support regulatory decisions for drugs and biologics Pharmaceutical and Biotechnology Alert

On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage information gathered from real-world...

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Blog Post

Four new FDA guidances and proposed rule advance biosimilars policy framework

Today, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological...

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Blog Post

China takes significant steps to consolidate generic drug industry and lower prices

On 7 December, China announced its newly implemented pilot centralized drug procurement program will cut prices for certain off-patent generic drugs by up to 96%. Under the program, China...

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Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Drug Pricing and Reimbursement

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.

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Hogan Lovells Publications

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling Pharmaceutical and Biotechnology Alert

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on ...

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Hogan Lovells Publications

Indonesia to relax foreign investment rules Finance Alert

As part of its 16th economic package, the Government of Indonesia (GOI) announced on 16 November 2018 that in order to attract further foreign investment, it intends to relax the...

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