SKIP TO CONTENT
Drug & Device Products
FDAnews Books Library
Form 483s Database
Webinar Training Pass
eCFR and Guidances
A Registered User?
If you are not a current registered user, please
Forgot your password?
FDA Ad and Promo Enforcement Trends: Past, Present and Future
Applying the Lessons of the Pandemic to Your Upcoming Trial
EU-MDR’s Growing Pains: Are You Current with the Latest Developments?
Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does
Medical Device Cybersecurity: Understand the Latest Developments
Pharmaceutical Process Validation: Best Practices for Success
FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485
Selecting and Implementing Electronic Document Management Systems in the EU
FX Receives FDA Clearance for Its FX V135 Shoulder Arthroplasty Platform
FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants
FDA Approves Foundation Medicine’s Companion Diagnostic for Genentech’s Rozlytrek
Novartis Pays $100 Million for Mallinckrodt’s Priority Review Voucher
The Revised ICH E8:
A Guide to New Clinical Trial Requirements