Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

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Band 1

What the Team is Known For

Covington & Burling LLP is a powerhouse in the pharmaceutical and medical device industry with extensive experience advising on product development, manufacturing and pharmacovigilance. The firm is retained by clients for its proficiency dealing with regulatory bodies, including the FDA and Consumer Product Safety Commission.

Work Highlights

  • Covington & Burling LLP represented Eisai in litigation against New Life Medicals under the CREATES Act, which challenged the validity of New Life’s demand for samples of Eisai’s LEQEMBI product. 

Strengths

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Notable Practitioners

Provided by Chambers

Peter O Safir
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Peter O Safir
S
Senior Statespeople
Peter Safir is a seasoned regulatory practitioner with impressive strength across a range of FDA mandates. His expertise includes enforcement proceedings and investigations.
Michael S Labson
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Michael S Labson
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Band 1
Michael Labson is a preeminent regulatory expert with notable strength in advising on compliance and contentious FDA proceedings. He routinely handles transactions and investigations on behalf of prominent life sciences companies.

Michael is highly commercial and practical in his advice. He knows the market and what is going to influence our decisions.

Michael is the best lawyer in this space, hands down. He provides excellent client service and always provides real-world business-conscious guidance.

Michael is the dean of the food and drug bar. He is really smart and understands the whole act. I take comfort knowing that I can call Michael for an enterprise-level 'above the fray' view.

Denise Esposito
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Denise Esposito
2
Band 2
Denise Esposito handles a wide range of issues for pharmaceutical and biotechnology companies, including the development and promotion of new drugs and digital health products.

Denise understands the FDA inside and out. Her regulatory advice is very pragmatic.

Krista Hessler Carver
2
Krista Hessler Carver
2
Band 2
Krista Hessler Carver maintains a broad FDA regulatory practice that includes advocating for policy changes. She counsels a variety of companies on complex matters, including responses to the Inflation Reduction Act.

Krista is a deep expert on all FDA and other regulatory matters. Her legal acumen is paired with a scientific background which means that her advice is grounded in a full understanding of the context.

Krista's knowledge of the FDCA and strategic thinking are commendable. She makes an amazing brainstorming partner and is always up for a legal challenge.

Pamela Forrest
4
Pamela Forrest
4
Band 4
Pamela Forrest is an experienced attorney who focuses her practice on medical device issues. She is routinely called upon to advise clients on FDA enforcement actions and warning letters, among other matters.
Scott D. Danzis
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Scott D. Danzis
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Band 5

Scott Danzis of Covington & Burling LLP is known for providing FDA regulatory support to clients in the life sciences arena, with a particular focus on medical device clients. He also handles FDA litigation.

Tom Cosgrove
5
Tom Cosgrove
5
Band 5

Tom Cosgrove of Covington & Burling LLP is recognized for a robust FDA regulatory practice, assisting clients with strategy, evaluation and guidance.

Tom's relationships and judgment are extremely valuable for us. He's so strategic and good at balancing risk and benefit. He helps us be strategic and pragmatic as a result.

Ranked Lawyers at
Covington & Burling LLP

Provided by Chambers
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Band

District of Columbia

Healthcare: Pharmaceutical/Medical Products Regulatory

Peter O Safir
S
Peter O Safir
S
Senior Statespeople
Michael S Labson
1
Michael S Labson
1
Band 1
Denise Esposito
2
Denise Esposito
2
Band 2
Krista Hessler Carver
2
Krista Hessler Carver
2
Band 2
Pamela Forrest
4
Pamela Forrest
4
Band 4
Scott D. Danzis
5
Scott D. Danzis
5
Band 5
Tom Cosgrove
5
Tom Cosgrove
5
Band 5