One way we hope to make things simpler for physicians is to reduce the amount of time they spend filling out a request for access to an investigational
Janssen Research and Development LLC has forged this new partnership with the division of medical ethics at the NYU School of Medicine to obtain independent advice, further ensuring that the evaluation of requests for investigational
medicines before their approval by the Food and Drug Administration or other global health authorities is carried out in a fair and ethical manner.
This planned initiation of the Phase II clinical trial reportedly follows the completion of a Phase I safety evaluation of the investigational
The first rule clarifies the agency's criteria for making investigational
drugs more widely available to patients.
Historically, patients accessed promising investigational
drugs once the agents were further along in the development process, typically around the time of Phase III trials.
drugs remain subject to section 501(a)(2)(B) FDCA which stipulates that a drug is adulterated if ' the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices to assure that such drug meets the requirements as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess'.
Advanced Biotherapy says the development of the investigational
drug for corneal transplant rejection could be applied to preventing organ transplantation someday.
If all goes well, an investigational
drug will end up in a phase 3 study where several hundred people receive it for 6 months or longer.
The physician agrees that this treatment is investigational
Random assignment helps to make sure that those in the group who receive an investigational
treatment are similar to those in the group who receive the control treatment.
Furthermore, CEL-SCI's response letter describes additional actions that the Company is implementing to ensure that its website and the statements about the Company's R&D activities and investigational
therapies on its website are in full compliance with FDA (DDMAC) requirements related to drug promotion and advertising.
The FDA is also launching a new web site where patients and their health care professionals can learn about options for investigational