Representative Experience
- Counseling on compliance with FDA, FTC, HHS and CMS processes and procedures, including responses to warning letters, Internet compliance, import and export compliance, 483 inspection reports, product recalls, injunctions and consent decrees, counseling IRBs and clinical trial compliance and management
- Drafting, submitting and reviewing documents necessary to obtain FDA approval or clearance of new drugs and new devices, including INDs, IDEs, NDAs, ANDAs, BLAs, PMAs, 510(k)s, supplements and all required premarketing filings
- Advising on orphan drug designation, fast-track review and pediatric exclusivity
- Preparing citizens’ petitions and FOIA requests, preparation of food additive petitions, GRAS affirmation and threshold of regulation petitions
- Reviewing labeling and advertising copy for compliance with the Federal Food, Drug and Cosmetic Act, the Lanham Act and the National Advertising Division of the Council of Better Business Bureaus
- Preparing regulatory comments in administrative rule-making
- Providing access to decision-makers within the FDA, CMS, HHS, FTC and OMB; use of Congress and state policy-makers to impact agency action
- Processing and negotiating collaborative research and development agreement