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
FDA plans to implement several measures to encourage use of Real World Evidence (RWE) in clinical trials, post-market pharmacovigilance and regulatory decisions. These measures include collection of feedback from stakeholders about ways to incorporate digital technologies in clinical trials to create better data collection and increase patient access to trials; and increasing FDA’s internal capabilities … Read more
The US government recently announced measures to curtail what it believes to be illegal activities by foreign governments to steal intellectual property. Although the announcement does not name any specific country, they use examples from efforts by the Chinese government, strongly pointing towards China as the primary offender. Many of the recommendations in these announcements … Read more
In an indication of the rapid growth in the number of digital medicine products to consumers and the increasing acceptability of their use for several healthcare applications, Best Buy, recently launched the “Best Buy Clinic”, a one stop location to purchase digital health products. The website lists products for real-time checking on one’s health status, … Read more
