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

With the statutory deadline approaching, FDA issues a proposed sunscreens rule Focus On Regulation

On 26 February, the U.S. Food and Drug Administration (FDA) published the proposed rule, "Sunscreen Drug Products for Over-the-Counter Human Use," which describes the conditions under which ...

Quick view Full view

Hogan Lovells Publications

Life sciences and health care horizons 2019

Quick view Full view

Hogan Lovells Publications

Brexit snapshot: Medicines

Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person...

Quick view Full view

Hogan Lovells Publications

DEA launches new ARCOS enhancement to help manufacturers and distributors "know your customer" and detect suspicious orders Pharmaceutical and Biotechnology Alert

The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that...

Quick view Full view

Webinar

The impact of Brexit on the pharmaceutical and medical device industries

Our European Life Sciences Regulatory team has been examining the potential consequences of Brexit for the pharmaceutical and medical device industries since before the results of the...

Quick view Full view

Hogan Lovells Publications

Podcast series: False Claims Act 2018 and the road ahead Podcast

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA...

Quick view Full view
Loading data