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Assisted a global medical device manufacturer in obtaining a variance from FDA’s Medical Device Reporting (MDR) requirements.
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Advised a global medical device manufacturer about FDA authority and response strategies while FDA investigators were on site.
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Served as FDA-regulatory counsel for underwriters to support securities offerings (SEC Form S-1, prospectus) for manufacturers of pharmaceutical drugs, biologics, and medical devices.
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Counseled clients on FDA regulatory matters, including Prescription Drug Marketing Act (PDMA) compliance; product development (NDA, BLA, ANDA, 510(k), PMA, orphan drugs, radiopharmaceuticals); drug and device registration and listing; 2253 submissions; competitor complaints; FOIA; Rx-to-OTC switches; and import/exports issues.
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Counseled a national drug distributor during a Congressional investigation into drug shortages and supply chain security.
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Assisted manufacturers of pharmaceutical drugs, biologics, and medical devices in coordinating responses to FDA enforcement actions, including FDA untitled and warning letters (e.g., FDA 483s, OPDP letters); and drafting trade complaints filed under the Lanham Act.
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Represent a national whole sale drug distributor as health care regulatory counsel for ongoing operational and compliance issues.
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Represent a national long-term care pharmacy company as health care regulatory counsel on ongoing operational and compliance issues.
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Counseled drug and medical device manufacturers on FDA regulatory issues related to acquiring, developing, and commercializing novel products.
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Assisted device manufacturers, initial importers, contract manufacturers, and manufacturers of active pharmaceutical ingredients (API) in resolving detention and import/export issues.
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