According to the guidance, that “safety and performance-based pathway” can be used by applicants to demonstrate that their device meets requisite criteria to support claims of safety and effectiveness, while also reducing the burden required by direct comparison testing against a predicate device.
Read more: https://incompliancemag.com/u-s-fda-releases-guidance-on-expansion-of-abbreviated-510k-program/
“There are a number of complex drugs that are no longer protected by patents or exclusivities that would forestall generic approval, yet they continue to face no generic competition owing to the difficulty of developing generics.
Read more : https://www.healthcarepackaging.com/article/fda-plans-advance-complex-generics
Dr Nicola Davies discusses the potential impact of 2018's US Food and Drug Administration approvals
Read more : https://www.thepharmaletter.com/article/a-record-in-fda-drug-approvals
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for 'economic stability' and to bring affordable drugs to patients.
Read more : https://www.in-pharmatechnologist.com/article/2019/02/05/us-fda-to-publish-additional-guidance-to-genericize-complex-drugs
A notable benefit of using wearable devices and other innovative technology to collect patient data in real-time is to encourage the design and implementation of clinical trials conducted at the point of care.
Read more : http://www.appliedclinicaltrialsonline.com/fda-policies-support-shift-decentralized-clinical-trials