Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Saf
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Understanding the Differences and Effectively Transitioning Between the US Integrated Summaries of Effectiveness and Safety (ISEASS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS) David N. Scbwartz, BS Senior Regulatory Strategist and Medical Writer, Michael Umen & Co, Glenside, Pennsylvania Michael 1. Umea, PhD President. Michael Umen 6. Co, Glenside, Pennsylvania Kathy Nomidrs Senior Regulatory Strategist and Medical Writer, Michael Umen 6.Co, Glenside, Pennsylvania Mary Vaaderhoof, MS Senior Writing Scientist. Johnson &Johnson Pharmaceutical Research & Development, Titusville, New leney
Key Words Integrated summary of effectiveness; Integrated summary ofsafety; Summary of clinical efjcacy; Summary ofclinical safety; Common Technical Document Carrespondrace Address David N . Schwartz, Michael Umen & Co, Inc, 352 North Easton Road, Glenside. PA 19038 (email: dschwartze umenandco.com).
The adoption in 2000 of the Common Technical Document (CTD) format for mmketing applications notwithstanding, the US regulations requiring an integrated summary of effidiveness QSE) and an integratedsummary of safety QSS) remain in effect.Many applicants, however, have attempted to use the CTD module 2 clinical summaries, specijically the summary of clinical efficacy (SCE) and the summary of dinical safq (SCS), alone to fulFll the regulatory requirementsfor an ISE and ISS,arguing that it is redundant to submit a separate ISE and ISS in addition to the SCE and SCS. Consequently, the US FDA has issued numerous guidances and made podium presentations communicating the message that, except in rare
INTRODUCTION Since the introduction of the Common Technical Document (CTD) in 2000, the US FDA has observed an increase in the number of New Drug Applications (NDAs) that do not contain sufficiently detailed and fully comprehensive integrated analyses of efficacy and safety. It appears that this trend is due to an attempt by some applicants to use module 2 , section 2.7.3 of the CTD, the summary of clinical efficacy (SCE) and module 2 , section 2.7.4 of the CTD, the summary of clinical safety (SCS) alone to fulfill the US regulatory requirements for an integrated summary of effectiveness (ISE) and an integrated summary of safety (ISS). To justify their actions, these applicants have argued that it is redundant to submit a separate ISE as well as an SCE and a separate ISS as well as an SCS. In reaction to this trend, FDA has on numerous
circumstances, New Drug Applications should contain the ISE and ISS documents as well as the CTD summmies of clinical eficacy and safety (SCE and SCS). The core differencebetween the ISEASS and their corresponding clinical summaries is in the depth of the analysa and the amount of information needed to support the analyses. While documenting the larger integrated analyses of eficacy and safety in the ISE and ISS,applicants should develop a strategy and process for deriving the SCE and SCS. Ultimately, submitting detailed and fully comprehensive ISE and ISS documents not only endes applic
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