Regulatory & Compliance Perspectives
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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.
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Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
8/29/2022
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
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FDA Seeks Comment On Conducting Remote Regulatory Assessments
8/11/2022
The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.
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Data: The Near Future Of Regulatory Info Management In Europe
7/29/2022
Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.
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How To Navigate Patent Eligibility Of AI-Driven Diagnostics
7/28/2022
The uncertainty in patent eligibility has had a chilling effect on patenting life sciences and computer software inventions. AI-driven diagnostics that lie at the intersection of these two fields face particular difficulty. This article shares tips from attorneys on how diagnostics companies can tackle their patent eligibility questions with more confidence.
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ISO 8655:2022 “Piston-Operated Volumetric Apparatus” FAQs
7/27/2022
Read the FAQs and learn, for example, what the revision of ISO contains and the differences with the previous version.
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Tips For Obtaining Your 510(k) FDA Clearance
7/8/2022
This article shares tips such as knowing when to apply for your 510(k) device clearance, mapping out an application strategy, using the pre-submission process, responding to FDA rejection of your application, and more.