UNAPPROVED IVDs COMMERCIALIZED UNDER INVESTIGATIONAL/RESEARCH-USE LABELING WOULD GET 18-30 MONTHS TO OBTAIN APPROVAL UNDER DRAFT CPG
This article was originally published in The Gray Sheet
Manufacturers commercializing unapproved in vitro diagnostics under the guise of research-use or investigational-use only labeling would have an 18-30 month grace period to gain FDA marketing go-ahead before being cited for violating premarket requirements, according to FDA's Jan. 5 draft compliance policy guide, "Commercialization of In Vitro Diagnostic Devices (IVDs) Labeled for Research Use Only or Investigational Use Only." The grace period would begin upon publication in the Federal Register of a notice of availability of the final CPG.
You may also be interested in...
As Bharat Biotech prepares its COVID-19 vaccine for a launch in the quarter ending next 30 September and claims at least 60% efficacy, questions arise over why trials were not temporarily halted following a serious adverse event during Phase I and why this wasn’t disclosed to participants in subsequent studies.
Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.
The first trial of the new Flash ultra-high dose radiation therapy with Varian Medical Systems’ ProBeam particle accelerator has begun. Agum Sharda, Varian’s senior director of Flash, says the technology could be a major advance for cancer patients.