Category: Standards

FDA, MHRA Continues to Facilitate Access to Ventilators Supply

March 30, 2020
Standards

As hospitals are in need of mechanical ventilation for an influx of patients due to coronavirus disease 2019 (COVID-19), regulatory bodies including the US Food and Drug Administration (FDA) and the...

Building Regulatory Capacity: Best Practices for the Future

March 26, 2020
Standards

Pharmaceutical companies are using various methodologies to ensure regulatory compliance with the health authorities. Still, there remains a loophole that prevents them from crossing the barriers set...

USA and EUROPE Looking Ahead to 2020

March 13, 2020
Standards

USA – Food and Drug Administration (FDA) The Center for Drug Evaluation and Research (CDER) continues its initiation to modernize the New Drugs Regulatory Program to better serve patients and to...

FDA Issues Guidances on Dual 510(k) and CLIA Waiver Applications

March 5, 2020
Standards

The US Food and Drug Administration (FDA) finalized two guidance’s providing recommendation for Dual 510(k) and CLIA Waiver by Application Studies. The purpose of this guidance is to help manufacturers...

FDA Launches New Interactive 510(k) Template Program

March 4, 2020
Standards

US FDA announced the voluntary electronic Submission Template and Resource (eSTAR) Pilot Program as an alternate method available for selected industry participants in the pilot to prepare a 510(k)...

TGA Issues New Guidance for TGO 101 (Standard for Tablets, Capsules and Pills)

March 4, 2020
Standards

The new guidance helps sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring...