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  • Regulatory NewsRegulatory News

    FDA Releases New Study Format Validation Rules

    The US Food and Drug Administration (FDA) has released a new document intended to provide a recommended approach for submitting study data for drugs and biological products using the Standard for Exchange of Nonclinical Data (SEND) standard. Background FDA accepts—and plans to require—submissions of drug products using electronic data submission formats adhering to accepted standards of formatting. The appropriate use of those standards will soon be of critical importa...
  • CBER Announces Electronic Submission Pilot Program

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) announced 28 February that it intends to conduct a pilot evaluation program for a new electronic data standard format to support application reviews. The new standard, developed by the Clinical Data Interchange Standards Consortium (CDISC), is known as the Standard for Exchange of Nonclinical Data (SEND). "FDA believes the use of standardized SEND datasets, together with ne...