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.
How many could Mr. Lewis answer?
Indeed, how many can you confidently answer?
- What type of drug development designations are available?
- How do I qualify for accelerated approval?
- If my product has an OTC monograph, what requirements do I still have to comply with?
- What are the steps to the drug development process?
- How can I use FDA’s Enhanced Communication Team to facilitate the drug development and approval process?
- What types of Investigational New Drug (IND)’s are there?
- What types of pre-submission meetings are there and which do I use when?
- When would an Advisory Committee by involved in the approval of my drug?
- How many types of drug submissions are there and which one is right for my drug?
- What is the FDA going to expect from me after approval in post-marketing surveillance?
The pre-market path for drug approvals is hard.
But do not proceed without someone who specifically focuses on drug submissions and regulations as I do.
And whether we work together or not, take this Regulatory Pathway Assessment with you.
+ Michelle +