The Healthcare and Life Sciences Team at Holland & Knight takes a comprehensive, multidisciplinary approach to serving the needs of pharmaceutical, biotechnology and medical device manufacturers. We have the range of legal experience essential to dealing effectively, throughout a product’s life cycle, with today’s increasingly complex regulatory and policy challenges, many of which are driven by the U.S. Food & Drug Administration (FDA), as well as the Centers for Medicare and Medicaid Services (CMS). This experience includes business planning and startup, finance and M&A; healthcare regulatory matters, including public and private reimbursement issues; federal and state legislation and appropriations; intellectual property; litigation (including mass tort defense); and strategic communications.
Our team draws upon the firm’s considerable resources, including major offices in Washington, D.C., New York, Boston, Atlanta, Chicago, San Francisco, Los Angeles and throughout Florida.
To maximize your opportunity to prevail on an issue, we assemble focused teams of attorneys to blend the necessary substantive knowledge with the procedural know-how to move the matter through the litigation process, the legislative process, or the regulatory process. Whether a matter requires informal consultation with agency or congressional staff, participation in public meetings, advocacy for particular report or bill language, or the preparation of comments on proposed rules or guidances, we have the talent and resources to get the job done effectively and efficiently.
Our ability to serve this sector of the healthcare industry is bolstered by the depth of our FDA-related experience.
Our team has a range of experience counseling clients on the review of New Drug and Biologics License Applications (NDAs and BLAs) including, from the Investigational New Drug (IND) stage through post-approval and marketing. Specifically, we have dealt with the following:
We have worked closely with CDRH as it continues to ensure the safety and effectiveness of medical devices and the safety of radiological products throughout the United States. Specifically, we have dealt with the following:
The Healthcare Team is comprised of Holland & Knight intellectual property litigators and prosecutors, including patent attorneys and agents with advanced degrees in science and engineering. Our lawyers have handled matters relevant to FDA and the healthcare industry including:
Team members have been involved in the development of most major FDA-related legislation in recent years including:
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