Are clinical trials submitted to the FDA/TGA/ETGA registered before the trials commence? I know that is best practice, but I am unclear whether it is regulated. If it is not, could there be a business in selling ‘pre-registration accreditation’, for pharmaceutical and medical device manufacturers to market their products for a higher standard of product?
Are clinical trials submitted to the FDA/TGA/ETGA registered before the trials commence? I know that is best practice, but I am unclear whether it is regulated. If it is not, could there be a business in selling ‘pre-registration accreditation’, for pharmaceutical and medical device manufacturers to market their products for a higher standard of product?