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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Bitesize Regulatory News 5 Oct 2021
USA FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are…
Continue readingFDA 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 readingWhat Are the Criteria for Enrolling People with Intellectual Disabilities in Clinical Research?
It is generally accepted that people with intellectual disabilities are not considered in clinical research if the type of the disease could be studied with people without disabilities. The reasons…
Continue readingWhat to Expect from the Changes in EU Clinical Trials Regulations?
If you are working with hospitals based in Europe or you are team member of a clinical trials team in a European hospital you are probably already aware of the…
Continue readingWhen Do You Need IND Application?
In October 2015 FDA released a clarification regarding IND application requirements. Their clarification is regarding queries and confusions amongst sponsors, investigators and RECs when do they need to apply for…
Continue readingCan You Start Clinical Trial Without Local Regulatory Approval?
Often clinical trials teams have country approval and Central Ethics Committee (CEC) approval but they have to wait for their Local Ethics Committee (LEC) approval as well. Some LECs are…
Continue readingClinical Trials: The Complicated Relationship with Regulatory Agencies
Alike all other highly regulated industries pharmaceutical industry also has its complicated and always changing regulations. As part of drug development process clinical trials also fall under specific regulations protecting…
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