Regulatory Counseling

RMMS recognizes that matters of a regulatory nature are tied directly to our clients’ business and commercialization goals, and also often relate to our clients’ patent defenses and litigation strategies for both small molecules and biologics products.

RMMS attorneys routinely counsel clients on regulatory strategies aimed at expediting the review and approval process for both small molecules and potential biosimilars under the Biologics Price Competition and Innovation Act ​(BPCIA), including matters related to product labeling, agency reviews, patent exchange and certification strategies, risk management programs, marketing exclusivities, and citizen petitions designed to delay and/or preclude approval of our clients’ products, including by imposing additional purity, bioequivalence and labeling requirements, just to name a few.

RMMS attorneys have had considerable success working with FDA to achieve our clients’ regulatory goals through written submissions (both through private controlled correspondence and through the public citizen petition process) and through meetings with Agency personnel. As a matter of example only, our attorneys have had success in persuading the Agency, among other things:

  • To accept labeling carve-outs and other changes to our client’s labeling;

  • To approve our clients' ANDAs for complex protein products approved under the Federal Food, Drug, and Cosmetic Act ​(FFDCA);

  • To deny Citizen Petitions designed to prevent our clients’ approval;

  • To grant 3-year new clinical investigation exclusivity for our client’s product; and

  • To issue a forfeiture decision that cleared the way for final approval of our client’s product.

Our goal is to assist our clients through the application, review, litigation and commercialization process, by staying abreast of the latest Agency and industry interpretations, guidances and pronouncements and by working closely with our clients and the Agency at each stage of the development, review, litigation, and approval process.