September 24th 2016; with the deadline, just a month away for Class II device Unique Device Identifier (UDI) compliance, it is our assumption, if not for sure, that all medical device manufacturers are well equipped with a comprehensive Regulatory roadmap. Besides having a firm grip over governance pre-requisites, manufacturers are expected to be audit ready for the compliance.
- August 23, 2016 Medical Devices, Compliance, Audit and Validation, Health Authority Updates
- August 11, 2016 Regulatory Labeling, Health Authority Updates
What does it mean for Australian Medicine Labels?
Will it be a sigh of relief for drug makers?
In a recent announcement pertaining to the Good Pharmacovigilance Practice (GPvP), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated that it no longer wants GPvP compliance reports to be submitted by organizations.
Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance.
- July 20, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
- July 19, 2016 Pharmaceuticals, Publishing & Submissions, Regulatory Consulting
Identify the best suited software ahead of time
With an aim to grab the maximum market share, drug manufacturers (innovators/generics) may sometimes wish to market their products, across the globe, which have already got approvals in one region. However, following a single regulatory approach for all the regions is almost a difficult task and perhaps not advisable.
- July 5, 2016 Regulatory Labeling
A bridge between U.S. and Worldwide Labeling Requirements
The US Food and Drug Administration (FDA) has recently released the optional final labeling rule specific to use of stand-alone symbols in order to align to the global standards for medical device and in vitro diagnostic (IVD).
The impact on Regulatory ecosystems in the UK and EU
Is it the time to be alert for drug and medical device manufacturers associated with the European Union (EU) and the United Kingdom (UK)? As Britain voted to leave the EU, the situation seems to be uncertain for drug/pharmaceutical companies to plan ahead with the regulatory processes, at least for a while into the future.
- June 21, 2016 Medical Devices, Regulatory Affairs, Health Authority Updates
With compliance deadline for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices finished recently, the FDA’s Center for Devices and Radiological Health (CDRH) has summarized the Unique Device Identifier (UDI) compliance date for Class II devices i.e., on September 24, 2016.
- June 16, 2016 Regulatory Software & Services, Health Authority Updates
Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming.