The eCTD Summit Celebrates 8th Anniversary with New Layout
Jan28

The eCTD Summit Celebrates 8th Anniversary with New Layout

While the online world has radically changed during the past 8 years, our approach of creating quality content has not. The eCTD Summit blog will continue to be a source of objective information on all things eCTD and regulatory submissions. Articles on the site are based on facts and stripped of bias. We want the site to be a trusted place our readers can regularly return to for updates on industry news, initiatives and best practices.

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FDA Module 1 Update Set for Q4 2014Ā 

The biggest change in the history of eCTD is one step closer to implementation. According to a notice posted this week on its website, the US FDA will be able to receive submissions using the new Module 1 specifications in the 4th Quarter of 2014. Industry will be given 30 days’ advance notice. The long-awaited update to the eCTD’s administrative section is designed to: Reflect regulatory changes Provide clarification of...

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Drug Development Costs Rise to $1.3 Billion

The cost of bringing a new drug to market is often cited as $1.3B according to a Tufts University study from several years ago. In this study, the $1.3B estimate is an increase of 60% from the previous estimate of $800M. Much of the cost associated with drug development is attributed to resources invested in drugs that never make it to market. Only one out of 10 drugs that are used as part of a clinical trial will become a marketed...

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Why are Drug Samples Disappearing?

The amount of drug samples provided to physician offices has dramatically decreased since 2007. From the period of time beginning 2007 to 2011, drug makers spent 25% less on drug samples which equates to $2.1 billionĀ¹. What’s behind this precipitous drop? Naturally, the cost-cutting measures undertaken by the pharmaceutical industry has impacted the number of samples provided by drug representatives. Nonetheless, the savings...

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MIT’s DRACO is a Novel Approach to Fighting Viral Pathogens

An innovative approach to fight viral pathogens has been discovered by researchers at the Massachusetts Institute of Technology (MIT). The new drug DRACO, an acronym for double-stranded RNA activated caspase oligomerizers, has the potential to fight many known viruses, including the common cold, flu, stomach viruses, polio, and many more. While the drug is still several years away from clinical trials, DRACO has seen early success in...

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Globalization of Drug Supply Carries Risks
Jun15

Globalization of Drug Supply Carries Risks

The amount of pharmaceuticals traded increases every year. In the US, imports comprise 40% of the drugs consumed and 80% of the ingredients needed to manufacture drugs. While such trade bolsters the economies of many countries and lowers the price of medicines by creating competition, real risks have affected the supply chain.

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