• Regulatory NewsRegulatory News

    EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias

    Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable. "While we acknowledge the need to avoid and manage any risk of bias, experience over the years shows that such risk can be managed by having in place the necessary safeguards and I can assure you that the Agency guarantees...
  • Regulatory NewsRegulatory News

    Industry Conflicts With FDA: The Options

    Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...
  • Updated Draft Guidance Describes Process for Dispute Resolutions for Drug Products

    The US Food and Drug Administration (FDA) has released a new draft guidance that describes the process by which those in the biopharmaceutical industry can initiate and elevate disputes regarding drug and biological products. The guidance is intended to apply to FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the two centers responsible for the review and evaluation of nearly all of the drug and biological...
  • CDRH Report Shows Steady Increase in Complaints, but Few Clear Reasons Why

    The Center for Devices and Radiological Health's (CDRH) ombudsman has released a report indicating that complaints made against the center and its employees have increased for a fourth straight year. The data-driven annual report is an accounting of the total number of inquiries, complaints, disputes and other points of contact made to the ombudsman's office during each calendar year. The report is meant to identify any lingering issues that might be affecting the agency...
  • European Ombudsman Chides EMA for Transparency Problems

    A report from the European Ombudsman calls on the European Medicines Agency (EMA) to increase the transparency surrounding its pediatric medicines testing requirements after finding an inconsistent application of regulations and a lack of disclosure from the agency. The inquiry was launched after two pharmaceutical companies-kept anonymous in the complaint, but reportedly Takeda and AstraZeneca -complained they were subject to an unfair application of EMA's 2006 Paediat...
  • 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...