Services

Product and Issue Specific Services

Provide Guidance and review of Company drug/device promotional materials; provide counseling and
advocacy on FDA medical device matters, including device clearance (510(k), PMA, etc.), and enforcement
and compliance issues. Assist in drafting FDA Warning/Unititled Letter response to close out
enforcement action and avoid further enforcement such as recalls and injunctions.

Clinical Research

Advice on solutions to issues involving subject informed consent, IRB approval, patient privacy requirements and GCP regulations.

Advertising and Promotion

Regulatory law guidance on drug/device promotional materials/campaigns and unbranded strategies. Advice on advertising of drugs/devices and labeling requirements under FDA regulations and guidances. Solutions to FDA warning or untitled letters.

Cosmetics

Guidance on FDCA classification of cosmetic products and voluntary cosmetic registration program eligibility.

Device/IVD

Solutions to legal issues around device/IVD classification and premarket notification, 510k and PMA approvals.

Dietary Supplements

Advice on regulation challenges regarding dietary supplements and interpretation of DSHEA and categorization of acceptable health claims for dietary supplement products.

Drugs/Biologics

Advice on regulation of drugs under FDCA including cGMP regulations, drug distribution licensing and product withdrawals/recalls.

OTC Drugs

Legal review of development of over the counter drugs under FDA monograph process including requirements of consumer research studies.

Crisis Management

Legal Guidance on management of FDA, OIG or DOJ related crisis issues effecting corporate reputation and ongoing business operations.