Dara K. Levy

Dara K. Levy

FDA Law
Recognized Since Recognized in Best Lawyers since 2025

About Dara

Practice Areas

Awards & Recognition

Office Locations

Reviews

4.3 / 5

0 Reviews

1,004 Profile Views

A

Amara Okonkwo

Jan 03, 2026

Exceptional responsiveness made our FDA approval process seamless

As a small biotech startup, we needed guidance on communicating with investors during pre-marketing. Dara was incredibly responsive—always available for urgent questions and providing clear, actionabl...

H

Henrik Johansson

Jan 03, 2026

Deep FDA expertise saved our medical device launch campaign

Our company was preparing to launch a new cardiac device when FDA raised concerns about our promotional materials. Dara's profound knowledge of FDA regulations—particularly her experience from CDRH—wa...

Y

Yuki Nakamura

Jan 03, 2026

Strategic import advice prevented costly FDA detention of our products

When FDA issued a Notice of Action threatening to detain our imported pharmaceutical ingredients, we faced potential production delays costing millions. Dara expertly interpreted the FDA notice and de...

F

Fatima Al-Rashid

Jan 03, 2026

Compassionate guidance during our most challenging regulatory moment

After receiving an FDA warning letter about our disease awareness initiatives, our team felt overwhelmed and uncertain. Dara approached the situation with remarkable compassion and understanding. She...

D

Diego Alvarez

Jan 03, 2026

Unparalleled professionalism in managing our global promotional review

As a Fortune 500 company, we require the highest level of professionalism from our external counsel. Dara exceeded our expectations as legal reviewer on our promotional review committee. Her meticulou...