One must strike the right balance between speed and quality.
– Clare Short
Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics: What is accelerated approval and how does it work?
The process is defined in 21 CFR 314 – Subpart H “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses”, but it is essentially a way of getting drugs through to approval faster. Not all drugs qualify; they must be designed to treat serious or life threatening illnesses and offer a benefit over current treatments.
Now, “faster” here does not imply shortcutting a thorough examination of safety and effectiveness. However, Subpart H allows the FDA to grant approval based on studies that use a surrogate endpoint (or “on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity”). Continue reading →
At Cato Research, part of our standard document preparation work for eCTD submission documents is to save every PDF file with the bookmarks collapsed (i.e. only the top level bookmark is visible when the document is opened). We’re often asked if there is a specific reason that we do this, since the FDA eCTD guidances don’t speak specifically to this issue. For the record, we collapse the bookmarks in every document in order to provide a consistent look from document to document throughout the application. One of our goals is always to create a positive user experience for the FDA reviewer, and ensuring that the reviewer encounters the same interface every time is big part of that.
Recently, this same question was raised in a discussion during a meeting of the GlobalSubmit Suite 2010 Beta Test group. Kathie Clark took advantage of GlobalSubmit‘s close ties with the FDA and took the question directly to the Agency. She learned that:
- CBER has been giving feedback in response to sample submissions that they would prefer to see bookmarks collapsed.
- CDER has not expressed a preference.
- No written guidance has been issued beyond what is included within the ICH eCTD Specification v3.2.2 (see page 7-4).
- FDA does not deem this issue as important enough for GlobalSubmit to include a check for it in the upcoming version of VALIDATE™.
Does your organization have a preference on whether bookmarks are collapsed or expanded? If so, what is your rationale?
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in July 2010 (links go directly to PDF documents).
This is a guest post by Catherine Sheppard, Ph.D. Catherine is a Senior Clinical Scientist in Cato Research’s Montreal, Canada office.
The evolution of medical imaging has greatly improved the rate and accuracy of diagnosis of disease in patients, this in turn has led to more timely treatment, and ultimately better prognosis for patients. Imaging during clinical trials is critical in the staging of disease for subjects at enrolment, following the progress of disease, and being able to accurately assess treatment effects.
Basic imaging techniques such as x-ray and ultrasound are implemented early in disease diagnosis as they are cheap and readily available. However, these low-resolution modalities have severe limitations in the accuracy of diagnosis and identification of early stage disease. Computer tomography (CT) provides higher resolution images, but harbors motion-related artifacts, requires sophisticated image reconstruction algorithms, and has low reproducibility over time and across operators. The evolution of magnetic resonance imaging (MRI) has lead to high quality, high contrast images, which allow clear delineation of anatomical features. Optical coherence tomography (OCT) has superior resolution to CT and MRI scanning, does not require ionizing radiation, and is less susceptible to motion artifacts; however, it requires a blood free environment and has poor penetration so only superficial structures can be visualized. Continue reading →
GlobalSubmit is hard at work on the next version of their software suite. In addition to several improvements to both REVIEW™ and VALIDATE™, the next update will also include PUBLISH™, their long anticipated eCTD and RPS publishing tool. As I’ve previously mentioned, I joined the GlobalSubmit team at DIA 2010 and was given a demonstration of an early version of the software. I was impressed with the new features, and so when GlobalSubmit asked me to participate in their beta testing program this summer, I jumped at the chance.
The GlobalSubmit team provided each of the beta testers – select regulatory professionals along with regulators at FDA and Health Canada – with a laptop that was preloaded with all of the latest GlobalSubmit software. Each week, GlobalSubmit hosts a webinar in which they introduce a new program or feature and explain its functionality. Then they turn us loose to test it out on our own and provide feedback. We have the ability to use demo submission files or to import actual eCTD applications of our own so that we can fully evaluate the software.
So far, I’ve had an opportunity to thoroughly test two of the most exciting new features in the suite, PDF validation and CrossCheck. Continue reading →
