Drug sponsor

In some instances, the FDA and drug sponsor (company/institution submitting the IND) will agree to hold a pre-IND meeting. This aims to acquaint the FDA officials with the background to/content of the IND application, and to get a feel for whether the IND application will be... 

The results of clinical trials conducted under an IND have traditionally been regarded as confidential business information that FDA was prohibited from releasing to the public under the Freedom of Information Act and that the publication of which was determined solely by the drug sponsor. The Food and Drug Administration Modernization Act of 1997 established a clinical trial data bank for drugs for serious or life-threatening disease and required the inclusion of information on all effectiveness trials for these drugs. As a result of widespread concern about the lack of public availability of information about all clinical trials and their results, individual companies and the Pharmaceutical Research and Manufacturers of America have... 

FDA scientists review the application to determine whether the studies the drug sponsor describe show that the drug is safe and effective for its proposed use. 

New Drug Application (NDA)—This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. 

The FDA outlines the justification for its decision in an action letter to the drug sponsor. When the action is either approvable or not approvable, CDER gives the sponsor a chance to meet with agency officials to discuss the deficiencies. At that point, the sponsor can choose to ask for a hearing, or correct any deficiencies and submit new information, or they can withdraw the application. 

The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet. 

According to these rules, Member States may, with some exceptions, make their own authorization at the national level. In this type of authorization, the drug sponsor submits an application to the regulatory authority of the country in... 

If the results from animal trials are favorable, the drug sponsor files an investigational new drug (IND) application with the FDA. If approved as an IND, the sponsor may begin testing the drug in humans. Human, or clinical testing, is divided into three primary phases. 

At the end of phase III, the drug sponsor applies for a new drug application (NDA). Results from clinical testing are reviewed extensively by the FDA, and if found favorable, the NDA is approved. At this point, the drug can be marketed and prescribed for use in the general population. 

NDA Web page provides resources to assist drug sponsors with submitting applications for approval to market a new drug. 

Measurement of a metabolite may be preferred when parent drug levels are too low to allow reliable analytical measurement in blood, plasma, or serum for an adequate length of time. The metabolite data obtained from these studies should be subject to a Cl approach for BE demonstration. If there is a clinical concern related to efficacy or safety for the parent drug, sponsors and/or applicants should contact the appropriate review division to determine whether the parent drug should be measured and analyzed statistically. 

In the past, only selected NDA candidate drug sponsors were encouraged to request an End-of-Phase 2 conference. Today, all holders of an IND for new chemical entities are entitled to this important conference. Depending on the workload of the division responsible for review of the IND, however, requests for a meeting for an end-of-phase 2 conference may be easier to arrange if the conference requested is for one of the following ... 

---