FDA Public Meeting on Enhanced Drug Distribution Security under DSCSA
“Patient safety is at the core of FDA’s public health mission; and ensuring reliable patient access to safe and effective medicines requires maintaining a closed, secure U.S. drug supply chain for the distribution and delivery of finished drug products” said Scott Gottlieb on February 28, 2018 at FDA Public Meeting…
Draft Guidance for Preparing a Pre-Request for Designation
On February 15, FDA issued a draft guidance on How to Prepare a Pre-Request for Designation (Pre-RFD). This guidance is intended to assist sponsors in obtaining a preliminary assessment from the FDA through the Pre-RFD process. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP)…
Metrics for Third-Party 510(k) Reviews
On January 26, 2018, FDA issued the first performance metrics for third-party reviewers of 510(k). Going forward, a summary of Third Party Performance Metrics will be posted on a quarterly basis. At this time, there is one Third Party Review Organization with at least 5 completed submissions. A Third Party…
Guidance May Not be Used as a Substitute for Rule making
On November 2017, Trump Administration issued a memo stating that “the Administrative Procedure Act requires notice-and-comment rulemaking when purporting to create rights or obligations binding on members of the public or the agency.” In the memo the Department of Justice stated that “The Department will no longer engage in this…
New FDA Efforts to Support More Efficient Development of Targeted Therapies
In recent years, the medical community has experienced a shift in the way health care is practiced. Rather than focusing solely on how to treat an overall disease type, medical innovators are now exploring how to tailor treatments that target unique characteristics of an individual’s disease, such as the genetic…
FDA Statement on FAERS and New Search Tool
The FDA’s Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the FDA. The database is used as a surveillance tool to help the agency look for new safety concerns that…