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It is well known that, the Food and Drug Administration (FDA) has been working to implement the transition of biological products which are currently approved as drug products and are ‘deemed to be licensed’ as biologics under the Public Health Service Act on March 23, 2020.
In the European Union (EU), a cosmetic marketing claim is regulated under EU Regulation (EC No. 655/2013). The Annex III – ‘free from’ claims were added on the July 3, 2017 to the list of regulations to be effective/mandated from July 1, 2019. At the same time the Annex IV ‘hypoallergenic’ claim was introduced.
In the current competitive landscape of Life Sciences, it is required to reduce the time-to-market for a quick product launch to take advantage of early success. For the same, manufacturers should ensure that all Regulatory aspects are adhered within the submission deadlines for successful approvals.
In a recent study in Canada, it was observed, “1 in 9 emergency cases were related to drug adverse events, and as many as 68% of those were preventable”. Prevention is better than cure. Having learnt that, the first and foremost task for the companies is to look at the ways that prevent the adverse events?
The dynamic environment of pharma regulatory for packaging artwork has set forth huge challenges in front of pharmaceutical and life sciences companies in terms of meeting the latest mandates. Subsequent to the rapid updates in artwork regulations, companies are facing one of the most crucial phases in their lifecycles.
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