iwewlkws It is hard to conduct placebo-controlled clinical trials, particularly in rare diseases. FDA released a new guidance document last week that provides ways to use historical controls to reduce and possibly eliminate placebo controls in all clinical trials. All diseases have a natural course under available standard of care which can be charted and used … Read more
FDA prefers that legacy clinical trial programs where a given product is tested through long clinical trials with generalized designs be replaced with modernized clinical development programs containing enrichment strategies, adaptive designs, master protocols, and operations supported by mobile technologies. Last week, FDA finalized two older guidance documents, one on enrichments strategies describing ways to … Read more
A recent study by researchers from MIT and Harvard University raise concerns about the risks of adverse reactions due to excipients in drugs, reporting that more than 93% of drugs containing inactive ingredients that could cause allergic reactions. The study, though well-intentioned, could create unreasonable anxiety and fear in patients taking the same drugs. All … Read more
Last week FDA launched a new online portal for patients, physicians, patient advocates and support groups can formally and directly request meetings with the FDA to discuss their disease and ask about specific FDA regulated products. Over the last few years, patients have been able to interact with FDA directly and that has led to … Read more
The clinical trial recruitment criteria must be modernized to accurately reflect measures needed for the safety of the participants, and to diligently evaluate the investigational product. This week FDA published five new Guidance Documents to rebut common exclusion criteria used for all clinical trials, specifically trials in cancer patients. The goal is to eliminate common … Read more
Medical device manufacturers will be able to send their proposed actions to address audit findings to FDA before formally implementing them, thereby avoiding unnecessary back and forth with the FDA. An FDA 483 lists all the findings of non-compliance at the audited site with the requirement that the manufacturer address all findings adequately within a … Read more
Patient recruitment issues afflict all clinical trials and a recent study shows that the main reason for such performance is not the availability of enough participants but the trial design. More than two-thirds of the participants either do not find trials or do not meet the strict inclusion criteria. Another 15 percent are not enrolled … Read more
An interesting study published last week found that the initial investor euphoria fizzled very rapidly after a company secured the highly coveted Breakthrough Therapy Designation (BTD) from the FDA. For small companies with one or few products, grant of the BTD by FDA led to an immediately upsurge in their stock value but the values … Read more
FDA announced a four-point strategy to increase scrutiny of imported food, effective immediately. FDA would increase foreign food facility inspections, increase inspection of shipments of food at ports of entry, improve it response time in case of food-quality related issues, and create a comprehensive inventory of human and animal food facilities and farms to better … Read more
Medical device manufacturers will be able to send their proposed actions to address audit findings to FDA before formally implementing them, thereby avoiding unnecessary back and forth with the FDA. An FDA 483 lists all the findings of non-compliance at the audited site with the requirement that the manufacturer address all findings adequately within a … Read more
