iwewlkws In JAMA this week, an article raises doubts about the safety and effectiveness of drugs approved by FDA via the accelerated approval program but a critical review shows that despite the concerns raised, the regulatory pathway does its job as intended. Drugs and biologics intended for life-threatening or serious conditions can be approved based on … Read more
An article in the New York Times this week discusses something that all sponsors of cancer trials know too well; there are not enough patients in the US for clinical trials with new drugs. One out of three active clinical trials or about 6300 trials currently recruiting patients in the US are for anti-cancer drugs. … Read more
The manufacturing process for any given FDA-regulated product could go through several changes, each of which needs to be reported to the FDA on a schedule based on the scope of the change. Manufacturers play it safe by sending most changes immediately which clogs the FDA reviewers’ time. This week FDA released a guidance to … Read more
Last week we discussed FDA’s revolutionary update to software regulation, namely establishment of a pilot pre-certification program for software developers with demonstrated high quality operations. This week FDA released its first guidance on the pre-cert program, in a question and answer format, further clarifying how the pre-cert pilot will work. The pre-cert program is open … Read more
About two years ago, in 2015, FDA launched an automated system for importers to submit shipment information for custom and FDA clearance and it has almost tripled the number of shipments that are cleared within minutes of arrival at the US ports allowing inspectors to quickly find the riskier shipments and focus their resources on … Read more
Last week FDA announced one of the biggest reshuffle in its policies for regulating software that should drastically reduce pre-approval regulatory burden on the developers and focus resources on evaluation of post-market consumer use data. FDA will change its traditional process for software as a medical device (SaMD) and use a revolutionary new approach to … Read more
This week FDA announced several initiatives aimed at greater patient engagement in regulatory processes that could greatly affect future approval decisions and other regulatory actions by the Agency. Involving patients in regulatory processes humanizes the regulatory process by educating consumers about how the FDA works. At the same time, it provides the FDA reviewers first-hand … Read more
About half of all BA/BE studies to support generic drug applications are conducted in India. On the other hand, only about 2% of interventional clinical trials have sites in India. And it does not seem that these numbers will change in the near future. To see the cause for this huge disparity, one needs to … Read more
Traditional clinical trials are designed to evaluate one drug in the treatment of one indication. Many patients are screened to find the few that perfectly match the inclusion criteria of the trial and rest are rejected. Screen failures could account for as high as half of the patients who initially showed interest in participating in … Read more
About half of all BA/BE studies to support generic drug applications are conducted in India. On the other hand, only about 2% of interventional clinical trials have sites in India. And it does not seem that these numbers will change in the near future. To see the cause for this huge disparity, one needs to … Read more
