FDA approval is primarily based on avoiding “false positive” or the Type I error, which means approval of a drug that is ineffective or harmful. FDA review is focused on making sure that all products it approves meet the minimum threshold of being safe and effective. According to a policy paper published by an MIT … Read more
In a news release today, it was announced that England approved its first electronic informed consent. There has been quite a lot of discussion regarding use of electronic or computer-based informed consent in clinical trials. The challenges of these I terms of added cost and time for creating one have not been fully addressed. FDA published … Read more
The European Commission (EC) released an opinion article last week highlighting its expectations on the minimum standards of qualification of GCP inspectors, in particular regarding their education and training. Per the EC, an inspector must have university level education in medicine, pharmacy, pharmacology, toxicology or other fields relevant to Good Clinical Practice principles. In addition, the inspector … Read more
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
FDA released a new internal policy on 17th Aug whereby sponsors of ANDA applications will soon start receiving timely updates regarding the status of their application’s review. Under this new policy the Regulatory Project Managers (RPMs) at Office of Generic Drugs (OGD) will respond to any status inquiries from authorized representatives of the companies within 2 … Read more
On 18th August FDA finally approved Addyi (flibanserin) popularly known as the “Female Viagra”. Third time was the charm for the manufacturer, Sprout Pharma, who learnt from there previous two failures and gamed the Advisory Committee using aggressive campaign to claim that their product should be approved despite all the safety concerns and marginal effectiveness because there was … Read more
Kim Kardashian tweets about a morning sickness drug and the world goes crazy. By this time, if you have not heard about it, you may be the only one in the world. But this is not the first time celebrity endorsements have been used by companies to make misleading claims. Celebrities are used to sell all … Read more
Antibiotic resistance is a mounting public health concern with the CDC estimating the annual added cost of treating antibiotic-resistant infections at $20 billion in the US alone. The CDC also estimates that 50-70% of hospital-acquired infections are now resistant to first-line antibiotics. Given the dearth of new classes of antibiotics, drug companies are looking at non-traditional approaches … Read more
