Newsletter - December 15, 2016
Real World Data For 505(b)(2) Development Programs
The 505(b)(2) regulatory pathway is primarily designed to get FDA approval of new indications of previously approved products. A provision in the 21st Century Cures Act, that became the law this week, could create a promising expedited approval pathway for 505(b)(2) products. Developers of such products need to conduct randomized clinical trials (RCTs) for the new indication. Read More
Electronic Informed Consent Gets More Guidance from FDA
Last year FDA released a Guidance Document regarding use of electronic informed consent in clinical trials. The use of electronic informed consent adds practical and logistical challenges to the informed consent process despite the obvious benefits. This week, FDA published additional guidance on a Q&A format seemingly to address the key concerns raised by users. The key process of informed consent does not change when electronic ICF is used...Read More
Real World Data For 505(b)(2) Development Programs
The 505(b)(2) regulatory pathway is primarily designed to get FDA approval of new indications of previously approved products. A provision in the 21st Century Cures Act, that became the law this week, could create a promising expedited approval pathway for 505(b)(2) products. Developers of such products need to conduct randomized clinical trials (RCTs) for the new indication. Read More
Electronic Informed Consent Gets More Guidance from FDA
Last year FDA released a Guidance Document regarding use of electronic informed consent in clinical trials. The use of electronic informed consent adds practical and logistical challenges to the informed consent process despite the obvious benefits. This week, FDA published additional guidance on a Q&A format seemingly to address the key concerns raised by users. The key process of informed consent does not change when electronic ICF is used...Read More
