Day: January 31, 2019

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