Food, Drug & Device Compliance and Planning

Alston & Bird offers an integrated international food, drug and medical device practice to help navigate the maze of regulatory compliance.  Our practice provides legal services to makers of food and dietary supplements; drugs, including Rx, OTC, generic and animal;  biologics, including monoclonal antibodies, viral vectors, RNA and DNA synthesis and gene transfer therapy; cosmetics; and medical devices and diagnostics and their clinical counterparts.  Our team of regulatory lawyers performs all the services required by an entity regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Health and Human Services Office of the Inspector General (HHS), the Centers for Medicare and Medicaid Services (CMS) and similar state agencies.  To deal effectively with cross-border concerns, we maintain an active alliance with numerous non-U.S. law firms for dealing with international regulatory issues.

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
• Peparing 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 agreements