iwewlkws 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
FDA announced yesterday that it has called about 400 inspectors back to their job, without pay. About two-thirds of these inspectors will continue audits of drug, device and biologics manufacturing facilities, and the rest for food inspections. FDA emphasized that all inspections or audit will be at “high-risk” manufacturing facilities with means that the efforts … Read more
In a news release this week, FDA leaders announced that they are forging ahead with increased enforcement of IND and BLA rules on cell therapy companies and expect to receive hundreds of new INDs within months. FDA estimates that by next year it will receive more than 200 new INDs for such products each year, … Read more
Just a few days before Christmas, FDA sent letters to several stem cell clinics asking them to respond to FDA’s finding that they are offering stem cell products that are not compliant with the law. The letters are gentle reminder that FDA is not going to ignore these clinics for long and that it intends … Read more
