The Food And Drug Administration

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The Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical device in context to granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, post-marketing surveillance of the medical product, etc. The Pharmaceutical companies seek for FDA approval for a new drug to be marketed through a long process. This process starts with applying an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that drug is safe effective.
On the other hand, there are many patients
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The expanded access purpose is not to obtain the safety or effectiveness data of a drug but to treat the patients .

There are three categories of expanded access under the FDA regulation:
Expanded access for Single patients, including for emergency use (21 CFR 312.310).
Expanded access for intermediate-size patient populations (21 CFR 312.315).
Expanded access for large patient populations under a treatment IND or treatment protocol (21 CFR 312.320).[1]
It is obvious that Andrea’s case goes under the expanded access for single patient.For each category of access, there are two types of regulatory submissions that can be used.

1-A new investigational new drug application (IND). Expanded access with the new investigational new drug application (IND) involves submitting a new IND or there is an existing IND in effect for the drug, but the sponsor of the existing IND declines to be the sponsor of the access use through a licensed physician (21 CFR 312.310). There is a review period of 30 days, and during this period the treatment cannot proceed (21 CFR 312.40 and 312.305(d)(1)). However, the FDA could notify the sponsor to begin the treatment process earlier. The investigator should have an agreement with the sponsor to supply the investigational product to the patient and the health care professional for treatment.[2]
2- A
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