Sentence examples for product submissions from inspiring English sources

Patient-reported outcomes (PROs) have recently gained greater credibility with regulatory bodies aiming to standardise their use and interpretation in RCTs, thereby supporting medicinal product submissions.

Although there are rising public expectations about the prospects for new therapies based on advances in biomedical discoveries, the rate of new product submissions to the Food and Drug Administration FDAA) has not been increasing.

In the past decade, the number of drug and biological product submissions to the United States Food and Drug Administration has been slowly declining, while biomedical research spending has increased.

The competition is the largest and most recognized design award in the world with 11,000 product submissions from 61 countries.

The key regulatory authorities have expressed interest in seeing PRO data included within product submissions.

?There is much work to be done on the product submission process including review of the physiological properties, potency and purity of substances, as well as in monograph development, standards of evidence, chemistry and manufacturing, and clinical trial development".

The Committee for Medicinal Products for Human Use raised several concerns about the applications, including inadequate product submission and failure to adequately demonstrate biosimilarity to the innovator product 32– 32.

The work was interesting and, through interaction with formulation scientists, I learned about product formulation and the range of studies beyond analytical that are required for drug-product submission.

Product license submissions must provide a comprehensive review of the evidence for the safety and efficacy of the product including evidence of traditional uses where appropriate [ 10].

The EU Directive requires retention for at least 5 years after trial end (for nonregulatory submission trials) and for a trial leading to a product licensing submission, at least 2 years after the last approval of a marketing application in the EU.

We also design a prototype system for product information submission for the sake of ad selection.