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
With the US government partial shutdown completing its 20th day, it is important for the regulated industry to understand that despite the event, many activities at the FDA continue as normal (as much as one can define “normal”). First, the things that don’t change. Pharmacovigilance activities continue as normal. Companies are still expected to report … Read more
Data quality and integrity issues are the most common reasons for 483s and Warning Letters. Many of these arise from misunderstanding FDA’s expectations from common issues related to data and documentation generation, correction, and storage. This week FDA released a new guidance on a Q&A format that discusses most common issues that all GMP facilities … Read more
It is no secret that FDA would like to regulate LDTs like other in vitro diagnostic (IVD) tests. FDA’s last attempt to do so in 2016 was withdrawn due to uncertain political conditions. Since then little has changed in the LDT space in terms of their use by patients, the number of providers, and it … Read more
