“In terms of their health practices, and particularly their FDA practice, they are in a class by themselves,” states one source.

Chambers USA 2020

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.

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. 

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