• Regulatory NewsRegulatory News

    FDA clarifies reporting post-approval changes for disposable manufacturing materials

    The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance  to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.   The guidance covers changes made to new drug applications (NDAs), biologics license applications (BLAs) or abbreviated new drug applications (ANDAs) and applies to all manufacturing establishments, including those that perform functions under contract.   During the...
  • Regulatory NewsRegulatory News

    FDA officials address common pitfalls affecting post-approval change applications

    The US Food and Drug Administration (FDA) offered some advice to help ensure smoother reviews of abbreviated new drug application (ANDA) post-approval supplements and addressed how certain changes should be categorized at the 10 November meeting of the Association for Accessible Medicines” (AAM) GRx+Biosim conference.   Officials were asked to address common issues affecting ANDA post-approval chemistry, manufacturing and controls (CMC) submissions. Agency officials ...
  • Regulatory NewsRegulatory News

    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
  • Regulatory NewsRegulatory News

    Making Changes to an Already-Approved Drug? FDA's New Guidance Wants to Help

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding how manufacturers of pharmaceutical products can make changes to their manufacturing equipment under FDA's scale-up and post-approval changes (SUPAC) requirements. Background After a pharmaceutical product is approved, its sponsor and manufacturer must work to meet ever-changing manufacturing standards, as well as demand for the drug. Though the drug product itself is still ap...
  • 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...