FDA Awards BioPharma $20M Contract for Generic Drugs Studies

The FDA has granted CRO BioPharma Services a lucrative contract to conduct human trials involving generic drugs as part of an agency assessment of its generic approval process.

Under the $20 million contract with CDER, the CRO will conduct in vivo studies of generic drugs over the next five years, the company disclosed last week.

The research is intended to help CDER address scientific questions in developing generic approval standards and ensure post­market safety and efficacy of approved generic drugs.