Advice is given on all aspects of the testing, development and marketing of these types of products This includes, in the drugs and biologics area, counseling on NDAs, BLAs, INDs, 505(b)(2) applications and supplements and amendments thereto, as well as on refusal to file and non-approvable decisions. Counsel is also offered on ANDA competitive and market exclusivity considerations, including life cycle management, special protocol assessments, as well as on matters relating to controlled substance regulation by the Drug Enforcement Agency pertaining to quota, scheduling, security, reporting, distribution and other DEA registration requirements; and on OTC drug status and regulation, including Rx-to-OTC switches. Informed consent, IRB, GCP and other clinical trial requirements are additional areas of the practice.

Assistance is also provided on clinical holds, GLP issues, advisory panel reviews, fast track and accelerated approval procedures, priority review, treatment INDs, advertising and promotional labeling matters, including off-label uses and other post approval matters. Products involving radiopharmaceuticals, gene therapy, pharmacogenomics, cells and tissues, as well as xenotransplantation, are all areas where help can be given with respect to testing, developmental, marketing, manufacturing and other strategic or compliance matters.. Other areas of the practice include conducting due diligence or compliance reviews related to product acquisitions, for example.

In the food area, advice is provided regarding food additive status and petitions; GRAS status, notifications, and GRASP petitions; color additive status and petitions; foods with health or nutrient content claims, foods for special dietary use, and FTC and FSIS related food matters. Counsel is given on dietary supplement regulation, animal feed issues, including on obtaining No Objection letters for animal feed products and on preparing animal food additive petitions, as well as on providing advice on feed regulation at the state level. Further assistance is provided in the area of labeling animal feed products with health claims.

Medical device products also constitute a significant portion of the practice. Advice is provided on all aspects of the testing, development and approval or clearance process for Class I, Class II, and Class III devices, including helping with the preparation of 510(k) and PMA submissions, and advising on IDE requirements and exemptions, substantial equivalence criteria, as well as on advisory panel review and post approval matters involving reporting and record keeping obligations. Counseling also is provided on related labeling, clinical testing and manufacturing issues, particularly with respect to in vitro diagnostic products, including their regulation as RUO and IUO products.