Sponsors have often complained that some divisions at FDA are inherently slower in responding than others. This trend permeates not only the review times for market approval applications but also to clinical trial applications and comment requests. In an article published in Nature Drug Discovery, senior officials at FDA acknowledged that different divisions do have different review … Read more
Since the onset of formal safety and efficacy testing of drugs before their market approval almost 60 yr ago, animal studies have formed the backbone of testing before a given experimental drug can be tested in humans. Supported by principles of ethical clinical research and sound scientific basis, regulators framed laws defining the kind of … Read more
According to a new survey, FDA approved 96% of market approval applications it received in 2014, and so far in 2015. This is a sharp increase from the year 2008 and before when the approval rate was close to 50%. So, is this true to say the companies are more likely to succeed in getting their products … Read more
