Prashant Kumar This week Innovio Pharmaceuticals and its manufacturing vendor, VGXI, got into a public disagreement regarding the terms of their contract which is a primer on vendor management for any company working with vendors in mission critical roles. Innovio would like to move commercial production of the most promising product in its portfolio to new vendors … Read more
About 2 out of 3 cancer drug approvals between 1992 and 2019 were based on surrogate endpoints and about 1 out of 3 surrogate endpoints were used first-time for market approval. A recent survey challenges the wide use of surrogate endpoints over direct measures such as overall survival. The authors found that about half of … Read more
This week FDA re-released a free tool for electronic informed consent to be used in clinical trials as an alternate to conventional paper-based informed consents. This is to help investigators obtain informed consent during the pandemic. But the tool seems to be of very limited functionality. It is hard to know if being free is … Read more
Tests that detect antibodies to the coronavirus in blood, serum and plasma have emerged as the key players in creating a feel-safe environment for re-opening our lives post-pandemic, and present an interesting safety and effectiveness paradigm for regulatory agencies. Antibody detecting tests can be designed to give results in minutes, do not require sophisticated equipment … Read more
FDA announced this week that it will no longer hold in-person meetings. All previously scheduled in-person meetings have been converted to phone meetings or written responses only. Many meeting requests will be delayed and may be denied. Among the impacts of the pandemic, this change will perhaps bite the most for the regulated industry that … Read more
About a month ago, it was being predicted that a treatment for COVID-19 may take several months and a vaccine may not be available for 12-18 months. These predictions got kicked with the emergency approval of Gilead’s remdesivir, and positive results from Moderna’s vaccine trial run by NIH, and this is not by chance. Both … Read more
Physicians are often coaxed by their patients to try the latest product approved by FDA or in the news. However, before a treatment decision is made, one must understand the clinical data that was used to support the market approval. While placebo-controlled studies may be the gold standard for the FDA approval of a given … Read more
Patients suffering from untreatable diseases could be helped by experimental treatments being evaluated in clinical trials. However, it is hard for most such patients to find well-matched clinical trials and to assure their enrollment in the same. What if the patient decides to fund a given clinical trial on themselves? Is it legal and is … Read more
Social distancing, frequent screening, extra hygienic practices and limited services are some of the precautions listed on FDA’s checklist for all restaurants planning to re-open for service. One big loophole; all guidelines are for the employees, no requirements for patrons. Which leaves it up to a given establishment to create rules for its customers. It … Read more
The Emergency Use Authorization (EUA) is a very important tool for fighting special circumstances but the COVID-19 emergency has exposed that these can be exploited financially by bad players. Since the declaration of the emergency, FDA has relaxed several rules governing personal protection equipment (PPEs) and, more importantly, the diagnostic tests. A unique policy announced … Read more
