Agency Experience

CTSW attorneys have appeared before the FDA as well as other government agencies, including the Federal Trade Commission, the U.S. Consumer Products Safety Commission, EPA and OSHA. Our multidisciplinary approach to regulatory law includes expertise in every facet of the field, from R&D, through manufacturing and labeling, all the way to product marketing and promotion.  Our attorneys have counseled clients on obtaining drug, medical device and consumer product approvals, responded to agency enforcement actions and prepared and assisted clients in implementing compliance programs.

CLAIM SUBSTANTIATION

In the area of claim substantiation, CTSW attorneys are experienced in guiding clients through the ever-changing labyrinth of FDA and FTC regulatory requirements.  We counsel clients with respect to the types of claims which may be made for their products, as well as in relation to competitor products.  We bring this regulatory expertise to bear not only in the context of product marketing and promotion but also in litigating cases under the Lanham Act and other advertising laws.

FDA APPROVALS, ENFORCEMENT & COMPLIANCE

CTSW attorneys are experienced in NDA and ANDA submissions. They have guided clients through FDA inspections, responded to 483s and warning letters, and advised on GMP compliance and post-approval activities (e.g., advertising, promotion and labeling).

KEEPING AHEAD OF THE CURVE

We vigilantly monitor FDA’s regulatory agenda for proposed rules and policies. Apprising our clients about significant regulatory initiatives before they take effect enables them to better plan for the future and to set longer term plans and goals.  By keeping our clients ahead of the curve, we provide them with the flexibility to take advantage of both short-term and long-term opportunities in a dynamic, and increasingly regulated, market.