• CDER Ombudsman: Smaller Companies Feel Confusion, Pinch of Regulations

    A report released by the Ombudsman's Office of the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) for 2011 says smaller companies are contacting it more because they are confused about which regulations apply to them and have more to lose from an adverse decision than do larger companies. Most of the commercial companies contacting the CDER Ombudsman, which mediates disagreements between the agency and outside entities, were "smaller, em...