Sentence examples similar to Investigational application from inspiring English sources

The goal moving forward is to submit for an investigational device application with the FDA.

The goal moving forward is to submit for an investigational device application with the FDA.

It means the FDA has reviewed it, and I'm sure is formulating questions and getting ready for additional candidates to submit their investigational drug applications.

It also said the company's product was a drug that could be used only under an FDA license or an investigational new drug application, but that no such licenses or applications exist.

This study was registered at http://clinicaltrials.gov (registration number NCT01766713) and approved by the Food and Drug Administration under an investigational new drug application from the principal investigator (R.L).

While many pragmatic clinical trials will meet the criteria for an exemption from the requirements for an investigational new drug application or investigational device exemption, in general, all clinical investigations of medical products that fall under Food and Drug Administration jurisdiction must adhere to regulations for informed consent and review by an institutional review board.

(7 IND means an investigational new drug application under part 312 of this chapter.

In order to offer it to patients, doctors would need to file an investigational new-drug application, or I.N.D., and obtain the agency's permission.

A second investigational new drug application is in preparation for F-18 fluoromisonidazole.

Typically, the FDA requires that companies first seek permission, through an investigational new drug application, or IND, before testing a new treatment in human participants.

The FDA's acceptance of the EDIT-101 investigational new drug application triggered a $25 million milestone payment from Allergan to Editas.