• Regulatory NewsRegulatory News

    EMA Touts Growth of Post-Authorisation Study Database

    The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database. The database, referred to as the EU PAS Register (European Union electronic register of post-authorisation studies), is operated by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), and was established with the aim of increasing transparency for post-authorisation studies. The EU Pass Regi...
  • Regulatory NewsRegulatory News

    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
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    FDA Clarifies how Generic Drug Companies can Change Their Manufacturing Processes

    A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic drug user fee amendments (GDUFA) program. Background A PAS is an application which seeks to make changes to an already-approved application , such as an Abbreviated New Drug Application (ANDA), which is used by FDA to approve generic drugs. Unlike other change notification ...
  • FDA Research Finds Women Under-Represented in Post-Approval Device Trials

    New research by regulators with the Center for Devices and Radiological Health (CDRH) has found that gender-specific data is not always assessed in postmarketing studies on the safety and efficacy of a device, potentially putting women at risk. Emphasis on Women CDRH, the US Food and Drug Administration's (FDA) medical device regulatory division, has been placing an increasing emphasis on the needs of women in recent years. In December 2011 it released a draft guidanc...
  • FDA Releases Generic Drug User Fee Schedule, Backlog Fees

    The US Food and Drug Administration (FDA) has released the last of its user fees for pharmaceutical products, disclosing the user fees payable to the agency for the submission of abbreviated new drug applications (ANDAs), prior approval supplements (PASs), drug master files (DMFs) and for the clearance of a backlog of ANDA submissions . Since the signing of the FDA Safety and Innovation Act by President Obama in July 2012, FDA has been steadily releasing guidance do...
  • FDA Wants Post-Approval Studies to Address Broader Public Health Needs

    The US Food and Drug Administration (FDA) is preparing a workshop to focus on the design and appraisal of studies conducted after the approval of a product to obtain further evidence of its safety or effectiveness. The studies, otherwise known as post-approval studies (PAS), are often used when there are outstanding questions regarding a product. Many products that receive accelerated approval from US regulators, for instance, must conduct PAS because their initial app...