We assist with product development strategy, pre-clinical activities and planning, clinical trials and cGCP compliance, applications and submissions for product approvals, cGMP compliance, post-market requirements and safety reporting, regulatory exclusivities, REMS design, advertising and promotion, citizen petitions, agency meetings, and international inspections. We also handle litigation under the APA and Lanham Act.
We work with all classes of medical devices, handling 510(k) clearances and pre-market approvals, cGMP requirements of the Quality System (QS) regulations, post-market compliance, safety surveillance, registration and listing, inspections, MDR reporting, recalls, and Emergency Use Authorizations.
We counsel on compliance with DSHEA, FSMA, FPLA, and the Bioterrorism Act, covering medical food, food additives, ingredients, and pet food industries.
We advise on FDA compliance for product packaging, labeling, advertising, cGMP, GLP, customs detentions, Warning Letters, Section 483 letters, market withdrawals, and counterfeiting issues. We also handle advertising challenges before the FTC and NAD, consumer class actions, and litigation under state unfair competition laws.
We represent clients on issues including nutrition and labeling, meat and poultry safety, perishable products, animal feed, organic agriculture, transgenic crops, plant pests, animal welfare, permitting, product development, and recalls.
