FDA Regulatory and Compliance

Our FDA Practice

Bringing regulated products to market involves navigating complex regulatory pathways that can significantly impact your timeline, costs, and ultimate success. When facing FDA requirements, having guidance that understands both regulatory expectations and business realities can make a meaningful difference. We work with companies at various stages of product development, from initial concept through market entry and ongoing compliance.

In the demanding environment of FDA-regulated product development, legal counsel that understands your specific regulatory challenges while integrating with your existing processes provides particular value. We offer FDA legal guidance tailored to your specific situation and product category. Our work focuses on moving alongside your team to address regulatory requirements, pursue appropriate approvals, and maintain compliance with applicable standards.

Whether you’re developing a new pharmaceutical product or managing compliance for existing medical devices, our work extends across FDA submissions, regulatory planning, and compliance management. We also provide support during FDA enforcement situations and post-market monitoring, helping clients through the various stages of product development and commercialization. With straightforward pricing approaches, we concentrate on addressing regulatory risks while keeping your business objectives and profitability in focus.

Product Approval & Clearance

FDA approval processes vary significantly across product categories. We provide guidance throughout these processes, including clinical trial considerations, preparation of regulatory submissions, and interactions with FDA personnel. Many clients find that early planning for regulatory pathways helps avoid costly delays later in development.

Ongoing FDA Compliance

Regulatory requirements continue well beyond initial approval. We help develop practical FDA compliance approaches for food, drugs, medical devices, and other regulated products. Our work includes navigating FDA guidance documents, managing regulatory submissions, and supporting compliance assessments.

FDA Inspections & Audits

FDA inspections create significant pressure for any regulated company. We assist with inspection preparation, provide support during active inspections, and help address post-inspection findings effectively. Proper preparation often makes a substantial difference in inspection outcomes and subsequent regulatory relationships.

Labeling & Marketing Compliance

Product labeling and promotional materials face strict regulatory constraints. We review and advise on labeling practices, promotional claims, and marketing approaches to align with FDA requirements. This preventative work helps avoid enforcement actions that can disrupt business operations and damage market position.

Enforcement Actions & Litigation

When facing FDA enforcement concerns such as warning letters or recall situations, having knowledgeable representation helps navigate these challenges. We work toward resolving regulatory disputes while minimizing operational disruptions to your business.

Regulatory Consulting for FDA-Regulated Industries

Different regulated industries face unique FDA challenges. We provide regulatory guidance across various regulated sectors, advising on compliance approaches, submission strategies, and ongoing regulatory management that align with your particular product category and business situation.

Frequently Asked Questions

How does the FDA approval process work?

The FDA approval process typically involves several steps, including preclinical and clinical testing, submission of a New Drug Application (NDA) or Premarket Approval (PMA), and review by the FDA. The process ensures that products meet safety, efficacy, and labeling requirements before being marketed.

What is the difference between FDA clearance and FDA approval?

FDA clearance typically applies to medical devices that demonstrate they are substantially equivalent to a legally marketed device. FDA approval, on the other hand, is required for new drugs, biologics, and some medical devices that must meet stringent safety and efficacy standards through clinical trials and other data.

What’s considered in my FDA regulatory submission?

When preparing FDA regulatory submissions, key considerations include ensuring the accuracy and completeness of the data, meeting submission format requirements, and addressing any specific concerns outlined by the FDA. Properly prepared submissions can expedite the approval process and reduce the risk of delays.

How should my business respond to FDA warning letters?

FDA warning letters are official notifications from the FDA indicating that the agency believes a company violates regulatory requirements. Businesses should respond promptly by addressing the issues outlined in the letter, implementing corrective actions, and communicating with the FDA to avoid further enforcement actions.

How does the FDA regulate the marketing and advertising of products?

The FDA regulates marketing and advertising to ensure that claims about a product are truthful, not misleading, and supported by evidence. This includes ensuring that promotional materials accurately reflect the product’s approved uses and do not make unapproved claims.

Where Can I Learn More About FDA Regulatory Matters?

The US Food and Drug Administration (FDA) regulates over $1 trillion of economic activity, including foods, drugs, medical devices, biologics, and more. Compliance with FDA regulations is critical, as the FDA can enforce laws under the Federal Food, Drug, and Cosmetic Act (FDCA). For more detailed information and guidance, you can explore the following resources: