KKB handles legal and regulatory issues associated with prescription
drugs and biologics – including development, FDA approval,
and marketing. Our focus is on strategic planning to minimize regulatory
problems and maximize the availability of safe and effective products.
We routinely negotiate with FDA on legal and policy issues, and
engage in litigation relating to FDA regulation and enforcement.
Our areas of practice include:
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Licensing and related issues for: |
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- Investigational New Drug Applications (INDs)
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Biologics License Applications (BLAs)
- Amendments and supplements to applications
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Compliance with post-approval requirements for changes in
products, labeling and manufacturing processes |
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Interpretation and application of FDA current good manufacturing
practice (cGMP) requirements |
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Establishment registration and product listing |
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Establishment, application, and product user fees |
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FDA reporting requirements |
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FDA enforcement proceedings, including the conduct of inspections,
responses to inspectional observations, Warning Letters, section
305 hearings, negotiation of consent decrees, litigation, and
implementation of FDA’s |
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Application Integrity Policy (AIP) |
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FDA-related import and export issues |
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Prescription drug labeling, advertising, and related marketing
issues including compliance with state law |
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Orphan drugs |
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Exclusivity for innovator drugs and generic drugs |
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Bioequivalence and substitution issues under federal and
state laws |
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FDA-related patent issues, including patent listing, patent
certification, and patent term extension |
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PDMA issues, including sampling, wholesale distribution,
and re-importation |
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Requirements under bioterrorism legislation |
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Assistance with recalls |
