So you want a new drug, do you?
Maybe you can help Mr. Lewis?
He wants a drug that won’t make him sick and won’t make his mouth too dry. One that won’t keep him up all night, sleep all day, or make him nervous.
Does he have any idea how hard it is to commercialize and mass market a successful drug?
There was nothing in his song about clinical trials, compliant labeling, or passing a PAI.
I bet he’d fail this quiz in spectacular fashion.
So brilliant and spot on. Love it! Hopefully the younger folks get the analogy. It definitely helps to have the video.
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21 CFR 211.265(f)Return to inventory – procedures
21 CFR 211.47(a)Donor eligibility procedures
21 CFR 211.47(a)Procedures for all steps
21 CFR 211.320(a)Procedures re complaints
21 CFR 211.265(e)Procedures and release criteria
21 CFR 211.75(e)Abbreviated procedure
21 CFR 211.230(a)Process validation procedures
21 CFR 211.190(d)(1)Procedures for cleaning, sanitation
21 CFR 211.200(c)Calibration procedures and schedules (general)
21 CFR 211.230(a)Validation & approval – established procedures
Shall I Continue?
No, you get the idea. I hate to see bad things happen to companies doing good, important work.In my storied (indulge me) career, I’ve seen one too many “If only so-and-so followed the procedure, we could have avoided this” messes that cratered otherwise-promising technologies.
Call me so you can avoid the same fate. Please?
How many could Mr. Lewis answer?
Indeed, how many can you confidently answer?
1. What type of drug development designations are available?
2. How do I qualify for accelerated approval?
3. If my product has an OTC monograph, what requirements do I still have to comply with?
4. What are the steps to the drug development process?
5. How can I use FDA’s Enhanced Communication Team to facilitate the drug development and approval process?
6. What types of Investigational New Drug (IND)’s are there?
7. What types of pre-submission meetings are there and which do I use when?
8. When would an Advisory Committee by involved in the approval of my drug?
9. How many types of drug submissions are there and which one is right for my drug?
10. What is the FDA going to expect from me after approval in post-marketing surveillance?
The pre-market path for drug approvals is hard.