Newsletter - August 5, 2021
Is FDA’s Accelerated Approval Pathway in Danger of Being Scrapped?
A review published in the British Medical Journal this week reported that almost 44% of drugs approved by the FDA under the accelerated approval pathway over the last 28 years have not yet been confirmed to be clinically effective, and despite that most of these unconfirmed drugs are on the US market for 5 years....Read More
Was FDA Short-Staffed to Handle the Pandemic?
The FDA has more than 18,000 full time employees and an annual budget of over $6 billion. It is high organized, and its regulators are considered some of the smartest in the World. It can handle challenges, or so it would appear to the lay person. Last year, FDA delayed many of its review activities due to the....Read More
Is FDA’s Accelerated Approval Pathway in Danger of Being Scrapped?
A review published in the British Medical Journal this week reported that almost 44% of drugs approved by the FDA under the accelerated approval pathway over the last 28 years have not yet been confirmed to be clinically effective, and despite that most of these unconfirmed drugs are on the US market for 5 years....Read More
Was FDA Short-Staffed to Handle the Pandemic?
The FDA has more than 18,000 full time employees and an annual budget of over $6 billion. It is high organized, and its regulators are considered some of the smartest in the World. It can handle challenges, or so it would appear to the lay person. Last year, FDA delayed many of its review activities due to the....Read More
