Regulatory
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FDA Releases Guidance On Cybersecurity In Medical Devices
5/31/2022
The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
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Therapeutic Oligonucleotides: Regulations & Quality Standards
5/20/2022
Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
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Patents Or Trade Secrets? How To Choose The Best IP Safeguard For R&D Assets
5/2/2022
There is no one-size-fits-all answer to the question of whether to pursue a patent or trade secret, but there are guidelines available for IP practitioners in these specialized fields where R&D is a key company asset and of paramount importance to protect.
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4 Pitfalls To Avoid With RWE For Regulatory Submissions
4/19/2022
Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both best practices and common pitfalls sponsors face. Avoid these 4 pitfalls.
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5 Key Steps For FDA Q-Submissions
4/18/2022
Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.
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FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs
4/14/2022
The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion cohorts to evaluate safety, anti-tumor activity, and other properties of oncology drug products, all within a single protocol. This article shares details of the guidance as well as advantages and risks of using this trial design.
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Biopharma Patents: Satisfying Descriptions For Claimed Ranges
4/11/2022
In pharma patents, ranges are often recited in patent claims to broaden the scope of the claim coverage. Claims may also include a temperature range or pH range used in making a drug. This article shares the key takeaway for industry from a recently decided court case.
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FDA Issues Guidance On Initiation Of Voluntary Recalls
4/5/2022
This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time.
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3 Essentials For A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
4/1/2022
In this article we discuss three essentials for designing a compliance strategy to ensure patient safety and data integrity throughout the decentralized drug development process.
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The Large Market For Medical Devices In Colombia May Surprise You
3/21/2022
Colombia has a population of approximately 50 million inhabitants, making it the third most populous country in Latin America after Mexico and Brazil. This article covers the general Colombian health social security system, the current medical device regulatory framework, and the size and trends of the market.