Yes. Theanalytical requirements should be agreed with MHRA Clinical Trials via theclinical trial application (CTA). If an activity defined as manufacture takesplace (see above) then the resultant IMPs should be tested to confirm that thespecification submitted in the CTA is met. There may be exc...
(MHRA) have approved Kanna Health's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to start participant enrollment in a Phase 1 first-in-human clinic...
as these documents do not form part of the clinical trial authorisation application. However, your report and comments on these aspects have been reviewed and considered with regard to the need for any regulatory action.
Can the Well-Established Use application be employed for IRP? The Well-Established Use (WEU) application, which has been well-established in the EU market for almost 10 years, does not require the submission of nonclinical or clinical studies for approval in the UK market. However, the IRP ...
Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, announced that the UK Medicines and Healthcare Products Regulatory Agency has approved the clinical trial application ...
PH1 is the most common and devastating form of PH and can cause severe damage to the kidneys by the deposits of calcium oxalate, eventually leading to End-Stage Renal Disease. In the pivotal clinical trial on 35 PH1 patients (Baum et al., 2023), nedosiran siRNA, a first-in-class drug...