Practice

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.

Hogan Lovells Publications

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program Health Alert

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services...

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Hogan Lovells Publications

Proposed additions of chemical families to Schedule 1 of Chemical Weapons Convention and BIS requests for comments from chemical, biotechnology and pharmaceutical companies International Trade Alert

On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC).

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Hogan Lovells Publications

Online sale of pharmaceuticals in Russia remains prohibited and lawmakers are yet to pass the bill allowing online sales

Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical ...

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Hogan Lovells Publications

Senate Finance Committee releases details of drug pricing bill Life Sciences & Health Care Alert

Yesterday, the Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Oregon) released a description of The Prescription Drug Pricing Reduction Act of...

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Blog Post

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.”...

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Sponsorships and Speaking Engagements

Introduction to Drug, Biologics, and Biosimilars Law and Regulation

Scott Kaplan will be presenting the segment titled "Regulation of Manufacturing" at the Food and Drug Law Institute's Introduction to Drug, Biologics, and Biosimilars Law and Regulation...

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