Mcdermott...
Life Sciences - FDA
McDermott Will & Emery has significant experience representing companies before the U.S. Food & Drug Administration (FDA). We provide legal guidance in business planning, product development, product testing and clinical trials, submissions to the U.S. Food and Drug Administration (FDA), marketing, compliance and enforcement matters, and congressional activities. Our clients include medical product manufacturers, public and private institutions, IRBs, academic medical centers, clinical laboratories, clinical research organizations, and principal investigators in various matters pertaining to clinical research. Members of the group have served at the FDA, on Capitol Hill, in the Department of Health and Human Services, on presidential commissions, in trade associations and in private companies.
The FDA Practice encompasses strategic and regulatory planning for product approval, compliance counseling—including promotional compliance, enforcement defense, and government relations, including legislative lobbying. A substantial part of our practice involved developing scientific consensus to support regulatory and legislative actions. We have experience in drug, device, biologics, in vitro diagnostics, food and animal drug regulation and have a long history of successfully representing clients in FDA-regulated matters. We also have experience in the approval, compliance and regulation of biotechnology matters, as well as substantial experience in oncology, including work on early access to unapproved cancer therapies and engagement with some of the world's foremost neuro-oncologists.
Lawyers practicing in McDermott’s FDA Practice have substantial breadth and depth of experience across multiple FDA-regulated industries, including medical devices and pharmaceuticals, in handling the following types of matters:
Clinical research
IRB procedures and investigations
Preparing approvable marketing applications through the FDA review process
Obtaining state and federal approval to field test and market new products
Developing policies and procedures for testing, manufacturing, quality assurance, packaging and labeling
Obtaining and protecting favorable formulary status
Audit inquiries and investigations by the FDA
FDA or equivalent EU-based regulatory issues arising from plant inspections, “warning letters,” product modifications and changes to intended uses that may require supplemental marketing applications
Comprehensive assistance from product research and development through commercialization for FDA related products by working seamlessly with practitioners in other domestic and international Firm departments, such as pharmaceuticals, biologicals, medical devices and in vitro diagnostics with Medicare, Medicaid and private payors
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