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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.
About a year after issuing the final rule for antibacterial soaps, where it has banned 19 ingredients, the US Food and Drug Administration (FDA) has come out with an announcement on similar lines.
The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
Do you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.
Since 31st August 2016, the Therapeutic Goods Administration (TGA) is continuously working to update its guidelines for labeling of medicines supplied in Australia to ensure companies be aligned with international labeling best practices and reduce medication errors.
In its latest announcement, European Medicines Agency (EMA) informed the Industry Change Liaisons that it has formally approved P&SMS Iteration 1 project covering Identification of Medicinal Products (IDMP) compatible authorized Human and Veterinary Products and Substances Management Services.
The regulations of the medical device industry in Europe may have remained relatively unchanged since the 1990s but recent upheavals such as the breast implant crisis and hip replacements resulted in immediate Regulatory reforms.
Ever since the FDA rolled out UDI rule, it has faced major hiccups down the road. Increasing concerns of medical device companies over deadlines is one among them. In a recent announcement, FDA yet again informed the compliance dates for certain Class I and Unclassified medical devices have been further extended....
With the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.
Codeine medicines seems to have attracted all the attention right now. Not for the ways they are to be used, but for the ways they need to be labelled and advertised. To protect children from serious risks, two top most health authorities, the US Food and Drug Administration (USFDA) and the Therapeutics Good Administration (TGA) have rolled out label and advertisement changes.
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