Bitesize Regulatory News 23 Nov 2021
USA A study looking into RWD from 50 post-approval confirmatory studies requested by FDA shows that data is inconclusive and difficult to analyse. The authors mentioned that some of the…
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FDA Legislation Changes: July 2018 FDA Extends Access to Experimental Drugs
FDA extended access program started back in 2009 and it allowed patients with life-threatening diseases who have exhausted all other options to try experimental drugs, which are not on the…
Continue readingClinical Trials and Restricted Medications
During my recent work I came across 2 cases of usage of restricted medications in patients participating in clinical trials. In both cases restricted medications were prescribed by GP or…
Continue readingClinical Trials and Medications Adherence
While medications adherence is important topic in medical community it is even more critical in clinical research. Accumulation of missed doses and unplanned dose interruptions in clinical trials could affect…
Continue readingSerious Adverse Events (SAEs) – How to Collect Important Safety Information in Clinical Trials?
Adverse events in clinical trials could be classified as serious in which case they are called Serous Adverse Events (SAEs). These events are critical for all clinical trials because they…
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