Every year CDER publishes a list of the guidance it plans to create or revise during the year. This year’s list was published in early March and it contains a number of interesting topics. Some of these we have already discussed (like “Rare Diseases: Natural History...
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Expanded Access Made Easier for Oncology Treatments
On June 3rd the FDAs Oncology Center for Excellence announced the launch of a new call center known as Project Facilitate to increase access to unapproved oncology therapies for use in patients who are not eligible for the clinical trial(s) for those therapies....
Draft Guidance on Master Clinical Trial Protocols
Expediting Development of Oncology TherapeuticsConferees at the American Association of Cancer Research in March had the chance to hear about master clinical trial protocols from Marc Theoret, who is the Lead Medical Officer in the Office of Oncology Drug Products at...
Summer Slow Down
Dear Readers:As summer starts, I’ll be reducing the frequency of my posts to give me a bit of extra time for some fun. Look for my updates twice a week (on Tuesdays and Thursdays) and be sure to contact me if you have a topic you’d like me to look into.Katrina
Patient Reported Outcomes Measures in Medical Device Submissions
Regular readers will recall my previous post on framework for Real World Data (RWD)/Real World Evidence (RWE) and its potential role(s) in drug approvals. Patient-Reported Outcomes Measures (PROM) can fill a similar role in medical device submissions. A PROM is a...
What’s the Difference Between a Pre-Sub and a Q-Sub?
The FDA’s Pre-Submission (Pre-Sub) program allows sponsors to request feedback from the agency on their planned medical device submissions. The original Pre-Sub guidance (issued in 2014 and updated in 2017) described 6 specific mechanisms for...
Producing a Generic Drug is Not Easy
At first glance, one might think that copying an innovator drug to produce a generic drug would be pretty simple. Most of the development work has already been done, and the generics producer only has to copy that information and receive approval for an Abbreviated...
Branded Apps for Real World Data Collection in the MyStudies API
The FDA released the code and technical documentation for their MyStudies Platform last November and hosted a full day of webinars in early May to orient developers on the system. All the webinars and complete documentation for the system may be found at this SBIA web...