FDA Awards $20 Million Contract on Generic Drug Research

FDA has awarded BioPharma Services a five-year, $20 million contract with CDER to conduct in vivo studies involving generic drug products in human subjects. The contract is intended to support CDER generic drug regulatory science issues, according to BioPharma. They will “proactively address scientific questions in developing generic approval standards and ensure post-market safety and efficacy of approved generic drug products,” it says. “Ultimately, the outcome of these studies will help improve the generic review practice within CDER.” CDER has previously identified generic drug post-market evaluations and complex products equivalence at the top of the list for regulatory science priorities in the Office of Generic Drugs (see story). Other priorities include equivalence of locally-acting products, therapeutic equivalence evaluation and standards, and computational and analytical tools.