The new EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts by each regulatory body to adequately regulate combination products. In Part 1 of this two-part series, we examined the U.S. regulatory guidance. In Part 2, we cover the European Union guidelines for combination products and show how the U.S. and the EU diverge.
One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.
The draft guidance calls for sponsors of new drug and biologics license applications to apply population PK analysis, which is frequently used to guide drug development on therapeutic individualization.
The new EU draft guidance Guideline on the quality requirements for drug-device combinations and U.S. draft guidance Principles of Premarket Pathways for Combination Products are the latest attempts by each body to regulate combination products. This two-part series examines the two guidances in detail; Part 1 covers the U.S. guidance.
This article explores some of the typical issues that may be encountered during recovery studies, and explains how the use of statistical tools for assessing recovery data can provide greater insight to guide decisions concerning recovery studies.
This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).
Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.
Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.
Any company with successful Phase 1 study data must ensure sufficient and consistent supply of drug product for possible Phase 2 and Phase 3 trials. For this reason, Phase 1 companies planning to outsource manufacturing of their clinical supply should take some essential steps early in the clinical manufacturing campaign to assure a timely and reliable supply of material throughout their clinical trials.
Repurposing idle equipment can add both hard and soft value to a company. Hard-value savings can be realized by putting good equipment back into service in another department or another site.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
For a pH sensor to maintain an accurate reading, the sensor must remain clean. Specifically, the glass measuring electrode cannot become coated, and the reference electrode assembly must not become coated, plugged or otherwise contaminated by the process solution. Here’s how to clean pH sensors to ensure correct operation.
Pharmaceutical suppliers are tasked with responding to ever-evolving changes in regulatory requirements, which impact everything within an organization—from operations to the way trials are conducted.
Biopharma executives must consider how outsourcing fits into their development and production strategy. Here’s a step-by-step guide to help make that decision.
Combination products in the medical device industry now occupy a substantial market segment. This article focuses on the maximization of global regulatory collaboration in the marketing of combination products.
Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.
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