FDA Brief: Week of Mar 7, 2016
- Drug Development Tool (DDT) : Clinical Outcome Assessment (COA) for Patient-reported outcome (PRO) instrument for Chronic Obstructive Pulmonary Disease (COPD)
- For exploratory use to measure respiratory symptoms in patients with stable COPD
- Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary : E-RS: COPD
- E-RS: COPD total score qualified for exploratory use as a PRO instrument to measure respiratory symptoms of stable COPD in clinical studies
- Additional development work needed to further assess measurement properties, including ability to detect clinically meaningful change, treatment effect on reducing respiratory symptoms from baseline levels
- Provide information on submission of initial pediatric study plan (iPSP) and amendments
- Addresses:
- Who must submit
- When it must be submitted
- What should be included
- What should be included in amendment
- Use of template
- Senate panel approved legislation on clinical decision support (CDS) software
- CDS represents a wide range of technologies, from common automated alerts and reminders to software that relays data to and from implanted devices
- Commonly used CDS tools help providers with drug-prescribing decisions
- MEDTECH Act Legislation bans FDA from regulating certain categories of software, including CDS software and electronic health records
- However, bill only exempts CDS if the software is designed to enable doctors to double-check the tool’s recommendation.
- Thus, majority of the software affected by the MEDTECH legislation is very low risk
- FDA also planning to develop CDS Guidance this year CDRH 2016 proposed guidances