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The impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared.
Artificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.
Did you know, as reported, every year almost 4500 drug products are called off from the US market? In the past few months, it is observed that the number of recalls has been increased drastically.
With each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements.
Are you a biosimilar/biologic product’s developer/manufacturer? Are you waiting for FDA’s latest stand on biosimilars or soon-to-be Biologics? Here it is. For the development of biosimilars and interchangeable biosimilars, on 11 December 2018, FDA released two new draft Q&A guidance documents under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
With 3,00,000+ Over-the-counter (OTC) products in the USA market alone, it is projected that, so far $105 billion have been saved in doctor visits, diagnostic tests and prescription medications. That makes us wonder, how come they be so cost-effective? Of course, it’s their ability to self-diagnose, self-treat, and self-manage and simple-to-use nature.
The advent of internet has fundamentally changed the course of action of almost every industry. Even though internet has been around for a while, it wasn’t until the emergence of Industry 4.0 that the digital transformation started helping the industries to evolve.
In our earlier blog on US Food and Drug Administration’s (FDA) current thinking on post-approval changes, we discussed, what application types do the FDA’s industry guidance on post-approval changes to drug substances applies to and what types of changes does it emphasize.
Do you know? The United States Food and Drugs Administration (US FDA) has yet again set a new record for the number of generic drug approvals. In comparison to FY 2017’s 937 approvals, FDA has approved a total of 971 generic drugs, so far this year which includes 781 final approvals and 190 tentative approvals.
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