• Medical device Modernization of 510(k) clearance, a pathway on Safety & Performance
    March 7, 2019 Medical Devices

    Did you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years. The approved devices include a range of innovative...

  • Brexit: Artwork Challenges for Pharma Industry

    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. Although the UK is in negotiations with the EU to streamline the transitions, the European Medicines Agency (EMA) has requested the pharmaceutical marketing authorization holders (MAHs) to stay prepared in advance to ensure...

  • Growing demand for halal products

    The demand for cosmetics and personal care products is rising exponentially across the world. Because of this rise in demand, trends related to the products, like vegan and organic, are prevailing now more than ever. One such trend is Halal products.

    But is there really scope for such products in the market? The answer is a definite yes! According to surveys, the global halal cosmetics...

  • Health Canada's action plan on Medical Devices
    February 20, 2019 Medical Devices

    Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same. The aim of the action plan...

  • MHRA and The Proposed eSubmission Portal
    February 18, 2019 Publishing & Submissions

    The impact of Brexit has been a major topic for debates amongst the industry experts for the past two years. It has left companies on both the sides, the United Kingdom (UK) and Europe, hanging on a loose thread. As the date of Brexit is drawing closer, industries are aggressively looking for contingency plans for sustaining their business, if the UK leaves with a ‘no-deal’. Coming to the...

  • Artificial Intelligence (AI) as a next big step for life science innovation, USFDA

    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. But unless the Regulatory constraints are eliminated, the AI will fall short of reaching...

  • Draft IVD Clinical Trials guidance from NMPA in China

    National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA), is all set to impose stricter regulations on auditing and reinforcement of clinical trials. To ensure best practices for in vitro diagnostic device (IVD), the agency released “Draft IVD Clinical Trial Guideline for Feedback” on November 22, 2018. The guidelines will come into effect in...

  • Nutrition Facts Label changes

    On May 27, 2016, the United States Food and Drug Administration (US FDA) published the final rule for nutrition and supplement facts label in the Federal Register. The final rule ensures that the label reflects new scientific information including the link between diet and chronic diseases like obesity and heart disease. The new rule intends to ensure that the product label is in line with...

  • 4 Common Reasons for a Drug Recall

    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. To name a few, a major drug manufacturer recently recalled 4800 bottles of HIV treatment drugs from the US market due to failed dissolution specifications; a US-based pharma company is set to recall...

  • Australia TGA’s Draft Guidance for Medical Device industry on Cyber Security

    Although digitization and Internet of Things (IoT) have together enhanced the performance of medical devices, they have also made devices prone to cyber vulnerabilities. The malware and spyware invading the devices are growing. The hackers are mining for loopholes in devices and related software that allow them to corrupt the devices to compromise user data by malfunctioning the devices. All...

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