Regulatory & Compliance Perspectives
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5 Steps To Eliminate Weak Links In Your Data Governance
12/2/2022
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
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FDA Vs. Congress: The Software Showdown
11/14/2022
September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016.
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LATAM’s Regulatory Framework For Medtech Early Feasibility Studies
11/11/2022
Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.
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India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
11/7/2022
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
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Should I Request A Q-Submission For My Medical Device?
10/31/2022
Q-Submissions are a mechanism available to request feedback from the FDA. It is the pathway for a medical device sponsor to reach out to request a meeting or written responses related to a product’s regulatory strategy or testing plan. The time and money for a Q-Submission pales in comparison with what is needed to correct testing and regulatory strategies later on.
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Tips For Your Virtual Meetings With The FDA
10/7/2022
It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.
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FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner
10/6/2022
Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.
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Human Factors Methodology In Medical Device Design For FDA Approval
10/3/2022
Human factors engineering processes are a critical component that should be considered throughout the full medical device development continuum rather than as a final requirement to check off at the end. This article shares tips for methodologies to enable FDA approval of your device.
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Life Sciences RIM: Modernization & Moving Ahead
9/28/2022
Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.
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8 Best Practices For Global Medical Device Patent Protection
9/8/2022
Medical devices demand unique intellectual property protection strategies. Preserve the valuation of your medtech during the early years of development and maximize revenue potential following regulatory approval with these eight best practices.