That's the largest number of new molecular entities in over 16 years, pretty aggressive.
You know, come up with the million dollar check for the PDUFA fee, things like that.
NEW DRUG APPLICATION (NDA) - authorSTREAM Presentation. Orphan Drugs: 21CFR Part 58 . This is information from December 2012 that he presented to CMS. So it's always funny to see is the US going to approve a drug first of is the EMA going to approve it first.
Now a lot of them are being paired or, you know, theyâre having co-marketing or partnership with these larger companies.
But thatâs really the driving force here. They actually approved 39 new molecular entities last year, 39.
And if you don't meet that threshold, you don't get it approved. Subpart B - Investigational New Drug Application (IND) (§§ 312.20 - 312.38) Subpart C - Administrative Actions (§§ 312.40 - 312.48) Subpart D - Responsibilities of Sponsors and Investigators (§§ 312.50 - 312.70) Subpart E - Drugs Intended to Treat Life-threatening and … And normally you'll have a conversation with the FDA again, but that's normally how it goes. Can specifically for like qualities economics or comparative effectiveness or anything else like that right now in the US system. So you can see here in 2012, 34, new molecular entities as of December. >> Yeah, like by Vivus or by Arena Pharmaceuticals or by a smaller company like that that's becoming more prevalent. It's not really the big blockbuster Pfizers, you know, Janssen, Sanofis that are really pushing this or moving, perpetuating this forward. So like a Vivus. So, CDER is meeting or exceeding all their PDUFA application review goals. 21CFR Part 56 . It's a federal entity, there's a lot of bureaucracy, there's a lot of rules that have to be followed. And it's really just based on, you know, the reviewers.
We are not set up. Why is the EMA approving something the US isn't? A quality amount that they give you. As a result of the significant disruption that is being caused by the COVID-19 pandemic we are very aware that many researchers will have difficulty in meeting the timelines associated with our peer review process during normal times. Please do let us know if you need additional time. A lot of our studies are using active comparators but we still have placebo control trials.
So they're really towards how can we improve the process. What [CROSSTALK]. That's what it really comes down too. This happens all the time. They would get to a certain state they would sell their agent to a larger company that had the infrastructure to sell, market. What they're seeing, though, is this shift, as we talked about. Name of Project, Initial IND Sponsor: Name of Investigator, MD Completed Form FDA 1571 Form included here . And I'll show you the numbers here in a second. because it's all socialized medicine, right? It's really these smaller companies. So, is it worth us paying for.
>> [INAUDIBLE]. So, I'm trying to give you the most up to date information.
Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.