FDA Lawyers and Consultants

FDA Regulatory Compliance with C. Humphrey & Associates, P.A.

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The Food and Drugs Act of 1906 was the first of more than 200 laws that constitute a comprehensive and ever changing regulatory authority of the U.S. Food and Drug Administration (FDA).  Examples of recent FDA legislative enactments include:

• The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, gives FDA the authority to collect user fees from  industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics;
• The FDA Safety and Innovation Act (FDASIA) includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as user fees paid to the  FDA by medical device companies when they register and list.  FDASIA changes how the FDA approves clinical trials and provides a new de novo  pathway for risk-based classification of devices;
• The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 and reforms U.S. food safety requiring new registration and  preventive control requirements for domestic and foreign food manufacturers and distributors;
• The Family Smoking Prevention and Tobacco Control Act  of June 22, 2009, commonly referred to as the Tobacco Control Act gives FDA authority to  regulate the manufacture, distribution, and marketing of tobacco products;

FDA regulates products accounting for roughly 25% of the United States gross national product – $1 trillion worth of products a year.

The practice of C. Humphrey & Associates P.A., is one of only a few law firms in the United States, led by Christine M. Humphrey, Esq., a former FDA investigator and FDA compliance officer, that concentrates primarily on FDA law, trade and regulatory compliance.

Our expertise extends to foods and dietary supplements, medical devices, pharmaceuticals, OTC drugs, biologics, biotechnology, animal feeds and drugs, cosmetics, and electronic radiation products.  Our FDA attorneys and FDA consultants provide proactive guidance to domestic and foreign clientele on product compliance reviews, labeling, product clearances and approvals, promotion and advertising, exports and imports, MDR reporting, QSR and cGMP requirements,  preparation for FDA inspections and meetings.  We respond to regulatory and enforcement actions including FDA483s, warning letters, injunctions, prosecutions, detentions, refusals, Customs penalties and FDA import alerts.

We distinguish ourselves in our ability to handle the most complex legal matters, while providing clients with a close, personal service often nonexistent in larger firms. Our FDA lawyers and FDA consultants pride themselves on their flexibility, efficiency and responsiveness.