Wayne Matelski is a leading attorney in ArentFox Schiff’s Food and Drug Practice and is the firm’s senior pharmaceutical and medical device attorney. Wayne concentrates his practice in the area of food and drug and controlled substance law, advising clients on their obligations and rights under the laws and regulations of the federal Food and Drug Administration, the Drug Enforcement Administration, and various related federal and state agencies.
Wayne’s work involves the representation of clients in the pharmaceutical, medical device, controlled substance, chemical, food, dietary supplement, and cosmetic industries.
He represents such clients on product development, preparing Investigational and New Drug Applications (INDs, NDAs, and ANDAs) and Investigational Device Exemptions (IDEs); Biologics License Applications (BLAs); medical device Premarket Approval Applications (PMAs) and 510 (k) Notifications; facilitating the entry of imported products through Customs; counseling on, and reviewing manufacturing plants for, compliance with good manufacturing and good laboratory practices; evaluating labeling and advertising claims; and defending against various types of enforcement actions taken by the government.
In the DEA area, Wayne has been counsel to a company that obtained approval of an application to import controlled substances (one of only four companies presently allowed to import such substances). This involved a multi-week administrative hearing before a DEA Administrative Law Judge and the subsequent successful defense of an appeal to the US Court of Appeals for the District of Columbia Circuit.
In addition, Wayne advises his DEA clients on a wide variety of DEA regulatory issues, including quotas, security and employee screening controls, drug diversion, company and physician enforcement matters, etc.
Wayne recently served as an expert witness for the Australian government in an enforcement action in Australia brought against a purveyor of internet prescription drugs. He also served as an expert witness in an arbitration involving a contractual dispute over an interpretation of whether a company exercised due diligence in pursuing approval of an NDA. The company for which Wayne was the sole expert witness was subsequently awarded all the damages it had requested, along with full attorneys’ fees, costs, and interest.
Outside of the food and drug field, Wayne has led and participated in general civil litigation matters, particularly in the area of defamation law and immigration class actions.
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