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
Can you use a mobile phone to capture endpoints in clinical trials? A study by Clinical Trials Transformation Initiative (CTTI) and FDA found that it could be very hard to develop such endpoints. This week CTTI release detailed recommendations on the process for creating endpoints using mobile phones. Mobile phones can capture a variety of … Read more
Generics drugs are several folds cheaper than innovator drugs, so a realistic way to lower drug prices is to encourage more generic versions of FDA-approved drugs. And finally FDA has taken several concrete steps to do just that. This month FDA announced a new regulatory class of generic drugs called the “Priority generics”. FDA would … Read more
FDA and FTC want consumers to help them find sellers of dietary supplements who make dubious claims or sub-standard products. Seems simple enough, but it is not. The agencies need stronger laws and additional resources to enforce the laws regarding supplements. Consumer complaints are not the answer. Dietary supplements account for about $100 billion sales … Read more
