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

FDA guidances promote greater communication to payors about medical product value Pharmaceutical and Biotechnology and Medical Device Alert

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

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Blog Post

EMA provides guidance on the sponsor’s role in validating electronic systems used in clinical trials

The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a...

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Hogan Lovells Publications

FDA proposes streamlining combination product regulations Medical Device Alert

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule...

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Blog Post

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal products and biosimilars

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorizations from stakeholders

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Hogan Lovells Publications

A new right for American patients: The Right to Try Pharmaceutical and Biotechnology Alert

On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients ...

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Blog Post

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). The agencies are...

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