iwewlkws 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
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
Tobacco use in middle and high-school students went up more than 36% in 2018 compared to the year before, most of it due to increased use of e-cigarettes. This during times when FDA’s enforcement activities such as audits of sellers of tobacco products to children, educational activities, and social media awareness campaigns by FDA were … Read more
In another flashy news designed to capture headlines, FDA issued Warning Letters simultaneously to 17 companies selling dietary supplements claiming to treat Alzheimer’s disease. In a detailed statement announcing the Letters, the FDA Commissioner listed several efforts FDA has implemented or planning soon to control dietary supplements. These include creation of special groups within FDA … Read more
FDA recently provided useful tips to developers of combination products that confirms well-understood processes while also providing more details to aid strategic development. Combination products offer an attractive option to provide a wholesome standalone product with convenient and reliable outcomes such a prefilled-syringes that offer ease for administration or patches filled with drugs that offer … Read more
FDA released its promised guidance on the least burdensome approach for medical devices this week which details the various options available to device developers for taking alternative approaches to regulatory submissions. FDA defined the least burdensome approach as “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the … Read more
FDA would create special criteria for complex drugs that are hard to genericize so generics could be created for them. Also, FDA would require manufacturers to provide timely and accurate updates to Orange Book information. Last year was a record year for generic drug approvals. FDA has repeatedly demonstrated that it wants to make it … Read more
