Newsletter - August 27, 2015
FDA Approves Practically All Market Approval Applications These Days
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 approved by FDA whether they are new molecules or modifications of earlier molecules? Does it mean FDA has become lax in its review? Has FDA become less conservative? This survey came at an opportune time when it is a universal perception that FDA got strong-armed to approve the first female libido drug. On the face value, this may seem to show that FDA is more liberal in approving drugs than it was 10 years ago but that is probably not true. More....
There is NO Viable Alternative to Animal Studies
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 animal testing needed to support the rationale of human testing prior to approval. But in the last 20 years there has been another strong voice, that of animal rights. And extensive research has been done to find out alternatives to animal testing. Since late 1990s, there has been a strong emphasis on computational biology to define better targets and in-silico or ex-vivo testing to avoid or reduce animal testing. More...
Different FDA Divisions Follow Different Times: Who Knew!
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 times but defended it by saying that this is because FDA prioritizes high-impact indications such as cancer and infectious diseases, hence areas such as psychiatric drugs, dermatology and dental products lag behind. Also most FDA’s Fast Track Designations, Breakthrough Therapy designations, and Priority Reviews are in the areas of cancer and infectious diseases, hence the imbalance in review times. More...
FDA Approves Practically All Market Approval Applications These Days
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 approved by FDA whether they are new molecules or modifications of earlier molecules? Does it mean FDA has become lax in its review? Has FDA become less conservative? This survey came at an opportune time when it is a universal perception that FDA got strong-armed to approve the first female libido drug. On the face value, this may seem to show that FDA is more liberal in approving drugs than it was 10 years ago but that is probably not true. More....
There is NO Viable Alternative to Animal Studies
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 animal testing needed to support the rationale of human testing prior to approval. But in the last 20 years there has been another strong voice, that of animal rights. And extensive research has been done to find out alternatives to animal testing. Since late 1990s, there has been a strong emphasis on computational biology to define better targets and in-silico or ex-vivo testing to avoid or reduce animal testing. More...
Different FDA Divisions Follow Different Times: Who Knew!
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 times but defended it by saying that this is because FDA prioritizes high-impact indications such as cancer and infectious diseases, hence areas such as psychiatric drugs, dermatology and dental products lag behind. Also most FDA’s Fast Track Designations, Breakthrough Therapy designations, and Priority Reviews are in the areas of cancer and infectious diseases, hence the imbalance in review times. More...
