ISSUE 2 : FEBRUARY 2019

The Veeda Newsletter

REGULATORY

U.S. FDA Releases Guidance on Expansion of Abbreviated 510(k) Program

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/

FDA Plans to Advance Complex Generics

“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

A record in FDA drug approvals

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


US FDA to publish additional guidance to 'genericize' complex drugs

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


FDA Policies Support Shift to Decentralized Clinical Trials

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

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