Regulatory
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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.
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FDA Releases Draft Guidance On Clinical Recommendations For “N of 1” Gene Therapies
3/15/2022
To eliminate ineffectiveness due to genetic differences, clinical trials of individual patients, described as an “N of 1” (single-subject) trial, can provide crucial insight. The regulatory path for conducting such gene therapy trials has been difficult to ascertain until now. This article shares the key takeaways of the FDA's draft guidance and provides an analysis for moving forward.
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FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations
3/8/2022
Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.
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3 Ways The FDA Is Taking Action On Lack Of Diversity In Cancer Clinical Trials
3/3/2022
Beyond issuing guidance documents, what actions has the FDA taken to ensure inclusion of relevant patient populations in cancer clinical trials? And what has been the impact? This article outlines three observations regarding the agency's recent efforts.
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The Clinical Trial Sponsor's Roadmap To Avoid EMA (Cyber) Perdition
3/1/2022
Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.