FDA Law Attorneys

Understanding FDA Law

FDA Law, formally known as the Federal Food, Drug, and Cosmetic Act (FD&C Act), is a cornerstone of the United States’ regulatory framework governing the safety and efficacy of food, drug, cosmetic, and device products. It’s a complex area of law, and ensuring compliance requires specialized knowledge and experience. Our legal team possesses the expertise to guide businesses through the often-challenging process of navigating these regulations.

We assist clients across a wide range of industries, including pharmaceutical, biotechnology, food and beverage, and cosmetic companies. Our work encompasses several key areas, including:

• New Product Development and Approvals: We assist in navigating the pre-market approval process, including preparing and submitting New Drug Applications (NDAs), 510(k) submissions, Food and Drug Administration (FDA) petitions, and other necessary documentation for product launch. We ensure submissions meet all regulatory requirements, minimizing delays and maximizing the chances of successful approval.
• Regulatory Compliance: Maintaining ongoing compliance with FDA regulations is critical. We provide guidance on labeling requirements, manufacturing practices (GMP – Good Manufacturing Practices), advertising standards, and post-market surveillance.
• Adverse Event Reporting and Product Recalls: We advise on the proper procedures for reporting adverse events associated with products, as well as assisting with product recalls, ensuring swift and effective action to protect consumers and minimize liability.
• FDA Investigations and Litigation: Our attorneys have extensive experience representing clients in investigations and litigation involving the FDA. This includes defending against warning letters, conducting internal investigations, and pursuing legal action when necessary.
• Food and Drug Law Counsel: We offer strategic legal counsel regarding product development, labeling, marketing, and distribution.

Specific areas of focus within FDA law include:

1. Drug Labeling & Advertising: Ensuring all drug labels and advertising materials comply with FDA regulations regarding truthful, accurate, and non-misleading information.
2. Medical Device Regulation: Guidance on the approval and regulation of medical devices, including premarket submissions and compliance with quality system regulations.
3. Food Safety & Additives: Advising on food safety standards, the approval of food additives, and compliance with regulations related to food labeling and traceability.
4. Cosmetic Regulations: Navigating the unique regulatory landscape for cosmetics, including ingredient restrictions and labeling requirements.

At our firm, we are committed to providing our clients with proactive legal support, protecting their interests, and helping them achieve successful outcomes within the complex framework of FDA regulations. We stay abreast of all changes in FDA policy and guidance to ensure our clients remain compliant and competitive.