patternofusa.com
About company
510(k) – Premarket Notification for Medical Device aka PMN AADA – Abbreviated antibiotic drug application ACTD – ASEAN common technical dossier ADR – Adverse drug reaction AE – Adverse event AIM – Active ingredient manufacturer AIMD – Active implantable medical device ANDA – Abbreviated new drug application API – Active pharmaceutical ingredient AR – Assessment Report (European Union) ASMF – Active Substance Master File ATMPs – Advanced therapy medicinal products BA – Bioavailability BAP – Biotechnology Action Program BIND – Biological investigational new drug BLA - Biologic License Application BWP – Biotech Working Party (EMA) C&P – Chemistry and Pharmacy CA – Competent authority CANDA – Computer assisted new drug application CAP – Centrally authorized product CAPA – Corrective action and preventive action CAPLA – Computer Assisted Product License Application CCDS – Company core data sheet CD – Controlled drug CDSCO – Central Drug Standard Organization (India) cGLP – Current good laboratory practice cGMP – C
