Regulatory
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2023's Market Outlook For Cell And Gene Therapies
2/14/2023
This article discusses quantifiable market trends, clinical developments, regulatory landscape analysis, and investment trends for cell and gene therapy companies in 2023.
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Persistent Noncompliance Leads To A Consent Decree
2/1/2023
What happens when failures are discovered repeatedly during FDA inspections, even after the company has been warned to correct them?
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The Modernization Of Life Sciences RIM
2/1/2023
A decade since we started tracking their ambitions for improving global regulatory information management (RIM), life science regulatory operations have achieved much in modernizing the immediate function globally and improving general operational efficiency.
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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 Releases Guidance On Drug Products Containing Nanomaterials
11/18/2022
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
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Frequent Deficiencies In GMP Inspections, Part 1
11/14/2022
It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
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Survey Reveals High Levels Of CTIS Adoption In Europe
11/8/2022
Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.
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Key Insights From The 2022 PDA/FDA Joint Regulatory Conference
11/3/2022
Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.
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5 Specifications That The FDA's Diversity Plan Needs To Include
11/1/2022
The FDA’s recommendations provide a much-needed action plan to jumpstart the changes that need to be made to ensure inclusive care, yet these recommended guidelines only scratch the surface of ideal action in clinical trials.
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FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics
10/20/2022
The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.