Under this tab you will find information about basic regulatory processes in the United States that pertain to drug Discovery, Development and Marketing.
I will discuss topics including the "IND", the "NDA", Protocols, Clinical Study Reports, Package Inserts, etc. Each of these topics will be addressed on a pull-down tab.
The studies conducted during Drug Discovery do not require any regulatory approval since they do not involve giving the drug to any humans. The FDA does not get directly involved in the Discovery phase.
If a drug performs well during Discovery, the Company may start a Development program. A Development program includes tests in a laboratory, in animals, and in humans to see if the drug will be safe enough and effective enough to be marketed as a drug product. Studies in humans are called "clinical trials."
Development studies will require a significant investment of time and money. During the Development phase, the drug being studied is considered to be an “investigational drug.” Investigational drugs cannot sold and can only be shipped to hospitals and doctors for study with FDA approval.
BioPharmaceutical companies who develop drugs become know as the drug "Sponsor". Before a Sponsor can start clinical trials with an investigational drug, the Sponsor must get permission from the FDA. To do this, the company files an Investigational New Drug (IND) application to receive FDA approval to start studies. The IND gives companies the right to ship an investigational drug to doctors and hospitals to conduct tests in humans. The IND tab will give you more details about this process. The IND includes nonclinical tests in the laboratory and in animals and clinical tests in humans. The IND phase may take several years if the drug does well. If early tests show that the drug is not safe enough for use or if it is not effective in treating the disease being studied, the company will stop the studies.
If the studies are successful the Sponsor can file a New Drug Applications (NDA) to get FDA approval to market the drug. More details are given on the NDA page. The Regulatory process is similar in other countries but the regulatory applications may have different names. In some countries, the application to start clinical trials is call a CTX (clinical trial exemption) instead of an IND and the application to market the drug is simply called a Marketing Application (MA) not an NDA.
I will discuss topics including the "IND", the "NDA", Protocols, Clinical Study Reports, Package Inserts, etc. Each of these topics will be addressed on a pull-down tab.
The studies conducted during Drug Discovery do not require any regulatory approval since they do not involve giving the drug to any humans. The FDA does not get directly involved in the Discovery phase.
If a drug performs well during Discovery, the Company may start a Development program. A Development program includes tests in a laboratory, in animals, and in humans to see if the drug will be safe enough and effective enough to be marketed as a drug product. Studies in humans are called "clinical trials."
Development studies will require a significant investment of time and money. During the Development phase, the drug being studied is considered to be an “investigational drug.” Investigational drugs cannot sold and can only be shipped to hospitals and doctors for study with FDA approval.
BioPharmaceutical companies who develop drugs become know as the drug "Sponsor". Before a Sponsor can start clinical trials with an investigational drug, the Sponsor must get permission from the FDA. To do this, the company files an Investigational New Drug (IND) application to receive FDA approval to start studies. The IND gives companies the right to ship an investigational drug to doctors and hospitals to conduct tests in humans. The IND tab will give you more details about this process. The IND includes nonclinical tests in the laboratory and in animals and clinical tests in humans. The IND phase may take several years if the drug does well. If early tests show that the drug is not safe enough for use or if it is not effective in treating the disease being studied, the company will stop the studies.
If the studies are successful the Sponsor can file a New Drug Applications (NDA) to get FDA approval to market the drug. More details are given on the NDA page. The Regulatory process is similar in other countries but the regulatory applications may have different names. In some countries, the application to start clinical trials is call a CTX (clinical trial exemption) instead of an IND and the application to market the drug is simply called a Marketing Application (MA) not an NDA.