An FDA question can arise before a product reaches the market or after an inspector has reviewed your facility. Dr. Martha Rumore brings a pharmacist-attorney’s understanding of the product to the legal review, supported by the firm’s former prosecutors and healthcare litigation team.
Health Law Alliance advises businesses whose products, facilities and communications fall within U.S. Food and Drug Administration (FDA) regulation. Our work includes drug and compounding matters, medical devices, cosmetics, over-the-counter products and dietary supplements. The legal questions depend on the product, its intended use, the claims being made and the business’s role in bringing it to market.
Our regulatory practice covers product planning and submissions as well as enforcement. That includes registration and listing support, labeling and advertising review, importation, clinical trial agreements, quality systems and commercial arrangements. A company preparing for launch needs a workable assessment of its proposed activities, not simply a response prepared after the FDA raises an objection.
If an inspection, Form FDA 483 or warning letter has already arrived, we examine the specific observations or alleged violations, the supporting records and the response requested. We coordinate corrective work with the legal response and assess whether related state, advertising or private-party issues also need attention.
For pharmacy businesses, our compounding pharmacy and Board of Pharmacy defense practices address the related operational and licensing matters.
Following are examples of representative FDA-related matters handled by Health Law Alliance attorneys:
We combine sophisticated legal counsel, courtroom expertise, regulatory and industry experience with deep scientific knowledge. We speak your scientists’ language and have our finger on the pulse of emerging technologies. We leverage our experience to assist our clients to achieve their goals. We work collaboratively to find practical and creative solutions. Our clients range from start-ups to large companies.
Our attorneys will assess the FDA’s concerns, the supporting record and any corrective work needed to prepare a substantive response.
Dr. Rumore’s practice extends from initial product planning through agency response and related disputes. The appropriate work depends on your product and role.
Depending on the product, the alleged violation and the agency action, the business may need to address:
Agency and company marks identify former professional experience of individual HLA team members. They do not imply affiliation, endorsement, or a client relationship.
Dr. Martha Rumore advises on FDA regulation, pharmacy operations and pharmaceutical products. Anthony Mahajan’s prior roles include federal prosecutor and Chief Counsel at McKesson. The firm brings regulatory counsel and litigation experience to the same matter, from reviewing a proposed product or commercial activity to responding to agency allegations.
Counsel can assist with planned business activity as well as an existing agency inquiry.
Additional questions about working with counsel. The answers below are general; specific situations require privileged consultation.
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