製薬業界が進化し続けるにつれ、薬事申請のプロセスも進化しています。重要な進展の一つは、eCTD (Electronic Common Technical Document) 4.0 の導入です。(eCTDを詳しくご存知ない方は、このブログをお読みください）。つづく...
Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)), and elsewhere. But developing each submission independently can waste a lot of time and money. Fortunately, there are ways to maximize the reusability of your … Continued
What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The … Continued
Your organization has numerous stakeholders responsible for reviewing the content of your drug submissions which requires approving eCTD submission content quickly, fielding agency questions on the fly, and often entails referencing in-stream as well as historical submissions to do so. The trouble is, without the right eCTD viewing software in place, simple yet critical review … Continued
Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists
The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program. Project Orbis Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international … Continued