iwewlkws Two new FDA Guidance Documents released last week describe in great details the various regulatory and scientific considerations for developing drugs and biologics for children. Two laws passed more than 20 years ago for pediatric drug developments mandate that all new drug approval applications either contain pediatric data or the plan to generate such data … Read more
Almost exactly 2 years after the launch of its clinical trial business in May 2021, CVS announced this week that it is shutting it down. While the company did not announce specific reasons for its decision, public information shows that the company was unable to successfully harness its access to tens of millions of patients … Read more
As Sarepta looks towards another controversial FDA approval for a new treatment for DMD, the accelerated approval pathway is once again being debated for its merits and abuses. Without major regulatory changes, there is not much that the FDA can do or want to do, while patients potentially get hurt both physically and financially. A … Read more
The last 5 years have seen extensive use of artificial intelligence (AI) algorithms for drug and medical device development. Till earlier this year, the regulatory discussions about AI were focused on medical devices but now FDA has released two white papers of use of this technology for the drugs and biologics, as well. FDA recognizes … Read more
As of today, 11 May 2023, the Public Health Emergency (PHE) for COVID-19 declared in January 2020 expired but this would not affect the various products authorized for Covid via Emergency Use Authorization (EUA). This is because under US laws, the PHE and the EUA are not linked. PHE refers to specific emergency measures to … Read more
The recent allegations of a NIH-funded researcher in Columbia conducting primate studies without proper ethics approval and conduct non-compliant with good laboratory practices (GLP) for non-clinical research have sparked outrage in the scientific community and raised important questions about the ethical standards that must be upheld in scientific research, in general, and US government funded … Read more
During the pandemic, completely or partially decentralized clinical trials (DCTs) became the only way clinical trials could be conducted reasonably, where possible. Although the dire necessity for DCTs is no longer there, their utility in increasing trial accessibility to a wider patient pool cannot be denied. FDA described eight considerations for DCTs which could determine … Read more
he Center for Veterinary Medicine (CVM) at the FDA has been accepting applications for new products electronically for a few years. But since CVM applications and documents follow a very different format compared to those for the human drugs and biologics, it has been confusing for companies to understand the acceptable electronic submission process. A … Read more
More than half of the cancer drugs are approved by the FDA based on non-randomized single-arm trials using surrogate endpoints. Also, many drugs for ultra-rare diseases with few or no options are approved based on open-label studies since including a placebo or a standard of care control arm is not feasible or ethical in those … Read more
Medical device manufacturers need to re-access if their device’s FDA approval or clearance is still valid upon making modifications to the device. Not doing a proper assessment could lead to FDA deeming the device illegally marketed. This hard lesson was learnt by Abbott’s Canadian unit selling a diagnostic test for quantitative measurement of cardiac troponin … Read more
