FDA Regulatory

Latham & Watkins FDA Regulatory Practice provides integrated and comprehensive legal services to medical device, pharmaceutical, biotechnology, dietary supplement and tobacco companies at all stages of development, from start-up and emerging growth to mature public companies.

Why Latham

Latham counsels clients in every aspect of the US Food and Drug Administration (FDA) regulatory process, as well as in policy and legislative matters. The firm's deeply experienced team has extensive industry experience and counsels clients in product development, launch and marketing, and with the government regulating agencies in every aspect of the FDA product life cycle, including:

  • FDA-enforcement action
  • Global clinical trial strategies
  • Manufacturing compliance
  • Market-exclusivity strategies
  • Post-market compliance counseling
  • Pre-market approval and clearance strategies
  • Product labeling, advertising and promotional strategies
  • Research, collaboration and commercial agreements 
  • Recalls
Comprehensive Expertise 

Legislative and Policy Matter Counseling 

Since 2000, Latham’s FDA Regulatory Practice has provided counsel in connection with nearly every FDA legislative initiative. Many members of the team have held prominent positions in US government executive and legislative branches and leverage this experience to provide strategic counseling and advocacy advice on FDA policy, legislative matters and governmental affairs, including:  

  • Analyzing, drafting and implementing legislative strategies
  • Writing regulatory comments for rule-making and legislative proceedings
  • Participating in hearings and panel meetings
  • Advocating with senior Executive Branch officials, members of Congress, and senior Congressional staff who have oversight of FDA, Drug Enforcement Agency (DEA) and other US federal agencies 

Contributing to the Success of Corporate Transactions 

Additionally, the FDA Regulatory Practice works closely with the Corporate Department on more than 400 transactions each year. Latham is recognized as the go-to counsel for life sciences capital markets, mergers and acquisitions, and private equity transactions and has earned the top spots in Bloomberg and Thomson Reuters league tables.

Defending Products Through Litigation

The FDA Regulatory Practice has also been involved extensively in Administrative Procedures Act litigation, including successfully challenging the FDA, as well as successfully intervening to defend FDA actions on behalf of clients. 

Awards & Rankings

Awards & Rankings content for FDA Regulatory
  • Latham Named 2019 Life Sciences Group of the Year - February 12, 2020
  • Latham Honored at the National Law Journal’s 2019 Professional Excellence Awards Ceremony - November 11, 2019
  • Latham Named D.C. General Litigation Department of the Year Finalist - June 02, 2019
  • Firm Recognized for Breadth of Life Science Practice in 2012 Industry Guide - June 30, 2012

Latham advises “a wide range of healthcare entities, including hospitals, laboratories and distributors, on complex investigations and transactions.” Their “interdisciplinary approach offers clients varied expertise in areas such as qui tam litigation and capital markets investment.” They “also act on administrative challenges and FDA regulatory issues.” 
Chambers USA 2018

Events

Webcast – FDA Regulatory Updates and 2020 Outlook for Vaping and Cannabis-Derived SubstancesFDLI Annual Conference

Media Coverage

Life Sciences Group of the Year: Latham & WatkinsLatham Named D.C. General Litigation Department of the Year FinalistFDA Focus: What Latham's Practice Chair Is Watching

News

Latham Named 2019 Life Sciences Group of the YearLatham Honored at National Law Journal Awards CeremonyHealthcare and Life Sciences Hot Topics: FDA Regulatory Considerations on Approvals for Artificial Intelligence

Thought Leadership

FDA Announces Planned Changes to the 510(k) Premarket Notification ProgramFDA Issues Draft Guidance on Orphan Drug Designation in Pediatric SubpopulationsFDA Issues Draft Guidance on Biosimilar Interchangeability

Webcasts & Podcasts

FDA Regulatory Updates and 2020 Outlook for Vaping and Cannabis-Derived Substances