• FDA Lays Groundwork for Study of Behaviors of Consumers and Healthcare Professionals

    A new contract announcement just issued by the US Food and Drug Administration (FDA) says it is looking for a contract partner with which to conduct behavioral research on how consumers and healthcare professionals react to promotional materials and labeling. The notice, known as a Request for Information (RFA), is intended to identify companies capable of conducting market research for FDA in the area of behavioral research. "The Agency is interested in organizations w...
  • FDA Hopes to Leverage Regulatory Science to Protect Public from Nuclear, Radiologic Threats

    The US Food and Drug Administration's (FDA) may be most known for its drug and device approvals intended to treat relatively common ailments-diseases, infections, cancer and inherited conditions-but every so often its activities venture into more exotic areas of regulation. Regulation: The Exciting Stuff Such an area was on display in a 12 August 2013 announcement in which FDA said it had awarded a $5.6 million contract to Harvard University to assess new medical counte...
  • FDA Announces Major Funding for WHO to Support Regulatory Capacity, Harmonization

    US regulators have announced a five-year, multimillion-dollar contract with the World Health Organization (WHO) intended to support regulatory science and enhance global regulatory capacity through improved harmonization and the development of standards. The Office of International Programs The funding opportunity is made available through FDA's Office of International Programs (OIP), now headed by John Taylor, acting deputy commissioner, and Mary Lou Valdez, associat...
  • New FDA Guidance Recommends Use of Quality Agreements to Define Contract Responsibilities

    The US Food and Drug Administration (FDA) has released a new draft guidance regarding contract manufacturing arrangements, establishing the responsibilities of each entity involved in the manufacture of a pharmaceutical product in adherence to current good manufacturing practices (CGMPs). Background The draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements , comes just as FDA has been identifying lapses in contract manufacturing arrangem...
  • IBM Awarded Huge Contract to Modernize Regulatory Review Processes at FDA

    The US Food and Drug Administration (FDA) has awarded a massive new contract to contractor International Business Machines (IBM) to help the agency improve its ability to review and analyze regulatory submissions the agency receives from pharmaceutical, medical device and biologic manufacturers. Background FDA first published a request for a proposal in July 2012, explaining that it was "seeking strategic and operational planning and other technical and user support, ...
  • FDA Looks to Assess Regulatory Results of Biologics Division

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is preparing to launch a program to evaluate the center's review processes, and in particular how it assesses statistical data through its Division of Biostatistics (DB). The program, explained in a contract notice posted on 23 August 2012, calls for an outside contractor to come in to evaluate the "reviewing capabilities" in the hopes of improving the regulatory review of f...