Top Industry News
- FDA requires use of eCTD format and standardized study data in future regulatory submissions
- UDI of the European Union compared to USA
- CDRH regulatory science priorities (FY2017)
- Clinical pharmacology review of new molecular entity (NME) new drug applications (NDAs) and original biologics license applications
- Drug development tool (DDT) qualification projects at CDER, FDA
- FDA-Self-Identification of generic drug facilities, sites, and organizations guidance for industry
- FDA-Data extrapolation to support pediatric labeling
- EMA-Meeting highlights from the committee for medicinal products for human use (CHMP)
- Australian public assessment reports for prescription medicines (AusPARs)