Expertise in all things FDA
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Expertise in all things FDA
Overview
Faraz Siddiqui, JD MPH provides drug and biologicals manufacturers with strategic regulatory counsel and advice to navigate the FDA review and regulatory process in all phases of the development lifecycle. Faraz also helps sponsors draft and review services and quality agreements with clinical sites, contract research organizations, suppliers, and licensees.
Faraz also counsels life sciences companies that market or distribute FDA-regulated products with HHS, CMS, and OIG regulatory and compliance issues as they relate to the Medicaid Drug Rebate Program, Veterans Health Care Act, and the 340B Drug Pricing Program. He advises companies on False Claims Act and fraud and abuse issues, including the federal antikickback statute, the Sunshine Act, PhRMA/AdvaMed Code, HIPAA, and complementary state statutes and regulations.
Faraz regularly uses his subject matter expertise to support internal investigations, litigation, and complex buyer-side transactions and public offerings for clients manufacturing all types of FDA-regulated products. He has supported client as brand attorney, providing legal and regulatory advice on promotion, sales, training, and market access. Finally, Faraz maintains an active pro bono practice and has fought for rights for the homeless and for asylum seekers in the United States.
Prior to law school, Faraz worked as a public health researcher at Georgetown Law School and as an epidemiologist at the Baltimore City Health Department. He completed his J.D. at Howard University School of Law and his Masters in Public Health at the Johns Hopkins Bloomberg School of Public Health. Faraz regularly blogs on drug pricing reform legislation and regulations and has published several peer-reviewed articles in the intersection of FDA law, policy and public health, including a paper in the Lancet. Faraz uses his public health background to provide a multidisciplinary approach to client support and advocacy.