FDA
Fun-damentals
Fun-damentals
This is the primary purpose of an IND.
This necessary skill or capability is delivering the right outcome on time, with clear communication and teamwork.
What is good project management?
This is the meeting with FDA before you submit your IND.
What is Pre-IND meeting?
This is an inspection that FDA conducts at the clinical investigation site to ensure the protocol and study requirements are being followed.
What is BIMO?
This type of electronic communication to HCPs can be considered pre-promotion.
What are emails?
This is typically the IND that companies pursue to eventually market the drug in the US.
What is good teamwork or collaboration?
This strategic document provides the foundation for your program. It includes the claims you intend to make once the drug is approved and the potential reimbursement approach.
What is the TPP (target product profile)?
This is one of the things that Start ups should consider as they move forward in their product development program. (Has Several potential answers)
What is 1) have a good attorney to help with contracts 2) have good regulatory strategy support 3) do diligence at your manufacturing sites to ensure high quality 4)have good documentation of your work and decisions?
What are conferences or booths?
This is the 'brakes' that FDA places on the IND if they are not sufficiently convinced your program is ready for the clinic and that your product is safe for clinical use.
What is a Clinical Hold?
This skill involves speaking clearly, engaging your audience and delivering a focused message.
What are good presentation skills?
This is FDA's primary concern when assessing the IND.
What is safety for the patient/subject?
These are ways to ensure you are selecting good research laboratories and or clinical investigators. (hint: tool for due diligence)
What is checking FDA, DOJ and SEC websites to ensure no warning letters or enforcement, debarment actions?
These are overt ways that FDA can cite companies for pre-approval promotion.
What are presentations or public interviews to investors?
This Center at FDA regulates certain biological products such as vaccines, cellular therapies, and blood products.
What is CBER?
What is writing your submissions in a clear an concise way?
These are approaches a company can take to streamline their submissions and potentially enable a faster approval.
What are expedited pathways?
Companies should ensure that their CDMO, clinical sites and other service providers are prepared to support these types of visits by FDA.
What are FDA inspections?
Who are spokespersons, investigators assisting your company?
This Center at FDA assesses drugs to approve them in the US.
What is CDER?
This is the benefit of having a good resource for regulatory affairs along your product lifecycle.
What is knowledge of the regulatory landscape?
In addition to clinical and nonclinical, this is a section of the IND that describes how your product is made and what testing you have done or will do.
What is the CMC section?
These are potential negative impact of clinical holds. (pick one of several)
What are negative press (stockmarket), what is delayed timelines and time to get your product to clinic-- and market, frustration from clinical investigators who have prepared for the trial?
Besides FDA, this is a group that can also pursue companies for their claims on investigational products.
What are DOJ and/ or SEC?