Agatha Archives

Complete Response LetterAn FDA letter informing an applicant of any deficiencies in their submission. Development,complete response letter,drug,application,response,diseases,treatment,review,factors,efficacy,biopharmaceutical companies,resubmission,time,request,Risk...

Common Technical Document (CTD)A CTD is a format used by pharmaceutical companies when submitting their marketing applications to the International Conference on Harmonization (ICH). Module,documents,registration,files,safety,drug,dossiers,Canada,Health...

Committee for Medicinal Products for Human Use (CHMP)"In Europe, the EMA's main task is to evaluate new drugs and medical devices before they become available on the market. It has three committees: one for medicinal products for human use (CHMP), one for cosmetics...

Clinical Trial Applications (CTA)“The European Union (EU) has a system for reviewing and approving individual research projects called Clinical Trials Authorisation. Each member state reviews and approves individual research proposals before they are accepted by the...

Clinical Study ReportA full report of a trial/studies of an investigational drug or device conducted in humans. Trial,study,time,safety,review,outcomes,risk,submission,placebo,adverse events,event,clinical study,product,clinical trial,clinical study reports,study...

Clinical StudyA research project involving human subjects (also called people), which aims to add to medical knowledge by investigating something new. There are two main categories of clinical research: randomized controlled trial (RCTs) and nonrandomized controlled...

Chemical Abstracts Service Registry Number (CAS Number)CAS Registry numbers are unique identifiers for each individual chemical compound. They are not intended to be used for any purpose beyond identifying a specific chemical compound. Substances,chemical,Chemical...