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 20, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
- 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.
IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines Agency) would want companies to start utilizing the defined terminologies to be submitted from July 1st2016. However, this has been further delayed according to the other industry sources.
- June 9, 2016 Cosmetics Regulatory Services, Health Authority Updates
The changing lifestyles and the increasing spendable income have been the major considerable factors for the shift in customer’s increased interest towards non-toxic cosmetic products and the growing preference for natural ingredients to be included. That made manufacturers across the globe to come up with more innovative products adhering to safety and efficacy regulations.
- May 26, 2016 Regulatory Software & Services, Health Authority Updates
In a general scenario, it is important to share the clinical trial analysis to increase the scope of further research and transparency in the flow of information. However, there are different levels of information that needs to be distributed to the public.
- May 24, 2016 Medical Devices, Health Authority Updates
The US FDA finalizes post-market surveillance guidance