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.

Published Works

China: Survival of the Fittest or Cheapest? Update Magazine

Senior Associate Xin Tao authored an article titled "China: Survival of the Fittest or Cheapest?" for Update magazine.

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Hogan Lovells Publications

FDA doubles down on MUsT studies for sunscreens and issues final guidance on absorption studies that will likely be needed for continued marketing Focus On Regulation

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied...

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Hogan Lovells Publications

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways Focus On Regulation

On 9 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application," that contains minor...

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Hogan Lovells Publications

DOJ issues new guidance regarding cooperation in False Claims Act investigations

Continuing its recent trend of revising and issuing new white collar enforcement guidance, the U.S. Department of Justice (DOJ) on Tuesday announced a new policy[1] governing when...

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Hogan Lovells Publications

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans Focus on Regulation

On 23 April, Food and Drug Administration (FDA) issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," which aims to clarify how firms in a...

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Hogan Lovells Publications

New OMB review process could impede FDA issuance of guidance documents Medical Device Alert

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents.

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