U.S. Food and Drug Administration (FDA)
Overview
Opportunities abound for companies to create innovative products that have a meaningful impact on consumers. Whether developing a potentially life-saving medical device or marketing a nutritious food or beverage, we help clients successfully meet U.S. FDA regulations, prepare for FDA inspections, and respond to notice of non-compliance and other agency inquiries. Led by a former FDA Associate Chief Counsel for Enforcement, we bring an insider’s understanding of how the agency thinks and acts to help our clients solve their most challenging and important regulatory problems.
- Pharmaceuticals
- Medical Devices
- Food and Beverage Products
- Dietary Supplements
- Cosmetics
- Animal Food and Drugs
- Tobacco Products
- Cannabis
- Product approval strategies
- New ingredient approval
- Manufacturing compliance
- Product labeling and advertising
- Reporting obligations
- Product recalls
- Answering agency inquiries
- Handling facility inspections
- Responding to observations and warning letters
- Seizure actions
- Injunction actions
- Actions for civil money penalties
- Contempt actions
We frequently partner with attorneys when client needs expand beyond FDA:
Contacts
Insights
Client Alert | 2 min read | 11.03.22
On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address health care disparities and promote health equity. In other words, FDA intends to specifically consider whether a device may provide for more effective treatment or diagnosis in populations impacted by health and/or health care disparities when determining eligibility for breakthrough status.
Client Alert | 9 min read | 10.10.22
FDA Issues Final Guidance on Clinical Decision Support Software
Speaking Engagement | 05.10.22
"FDA Enforcement and Regulatory Trends: What’s Ahead in 2022?," Crowell & Moring Webinar, 2022.
Representative Matters
- Advised an international ready-to-eat food manufacturer on a variety of food safety compliance issues including meeting obligations under the Food Safety Modernization Act; implementing preventive controls across multiple manufacturing sites; advising on criteria for reporting concerns to FDA and preparing submissions to the Reportable Food Registry; responding to findings of objectionable pathogens in food and food preparation areas; coordinating recalls of products presenting safety concerns; navigating FDA inspections at multiple manufacturing sites; responding to FDA inspectional observations; and facilitating meetings with FDA to present on and discuss advances in food safety.
- Helped a client develop strategy in response to FDA recall demands following discovery of salmonella in the client’s manufacturing facility. We guided the company through meetings with FDA officials, including with the Director of FDA's Center for Food Safety and Applied Nutrition, to arrive at a reasonable recall plan to ensure consumer safety.
- Assisted a large international retailer with entering the U.S. market and developed their consumer product safety compliance program. We worked with them to ensure their products met all U.S. regulatory requirements, including FTC labeling requirements and CPSC and FDA mandatory and voluntary standards. We also built their compliance program from the ground up, drafting both their product safety policy and vendor management handbook.
- Advised a drug manufacturer on its response to FDA compliance concerns, leading to the lifting of a Warning Letter.
- Advised executives at drug manufacturing and drug compounding facilities in consent decree negotiations with FDA, leading to the eventual withdrawal of the consent decrees.
- Advised a medical device manufacturer on strategies for securing emergency use authorization and other pathways to market.
- Advised a medical device manufacturer on strategies and development of 510(k) submissions.
- Advised prospective investors in cannabis operations on applicable regulatory frameworks and risks.
Contacts
Insights
Client Alert | 2 min read | 11.03.22
On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address health care disparities and promote health equity. In other words, FDA intends to specifically consider whether a device may provide for more effective treatment or diagnosis in populations impacted by health and/or health care disparities when determining eligibility for breakthrough status.
Client Alert | 9 min read | 10.10.22
FDA Issues Final Guidance on Clinical Decision Support Software
Speaking Engagement | 05.10.22
"FDA Enforcement and Regulatory Trends: What’s Ahead in 2022?," Crowell & Moring Webinar, 2022.
Insights
Professionals
Insights
Client Alert | 2 min read | 11.03.22
On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address health care disparities and promote health equity. In other words, FDA intends to specifically consider whether a device may provide for more effective treatment or diagnosis in populations impacted by health and/or health care disparities when determining eligibility for breakthrough status.
Client Alert | 9 min read | 10.10.22
FDA Issues Final Guidance on Clinical Decision Support Software
Speaking Engagement | 05.10.22
"FDA Enforcement and Regulatory Trends: What’s Ahead in 2022?," Crowell & Moring Webinar, 2022.
