There are two IND categories: Commercial and Research (non-commercial).

There are various types of drug applications submitted to the FDA, including Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Over-the-Counter Drugs (OTC), and Biologic License Application (BLA).

The Prescription Drug User Fee Act (PDUFA) of 1992 allows the FDA to charge fees to applicants submitting drug applications or sponsors of approved prescription drugs.

Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.

Type of AE: This refers to any unfavorable and unintended sign (including abnormal laboratory findings not meeting the criteria for an AE) that occurs during or after treatment with the test article.

The choice of a radiolabeled molecule for a radiopharmaceutical drug depends on several factors, including the target tissue or organ, the specific disease being studied, and the desired properties of the radiotracer.

There are 11 NDA Classification Codes.

Death is not an AE because it is a final outcome of the patient's condition, rather than an adverse event itself.

The subjects should be informed about any changes in the protocol and asked for their consent before proceeding with the new procedures.

The FDA's priority review process is designed to expedite the development and review of new drugs.

Drug infusion rates are often controlled in clinical trial protocols to ensure that the study participants receive a consistent and safe dose of the drug being tested.

Priority review is intended to expedite the FDA's review of new drugs and vaccines that have the potential to offer significant improvements over available therapies for serious conditions.