Regulatory
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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.
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Tips For Your Virtual Meetings With The FDA
10/7/2022
It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.
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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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FDA's RTOR Program: Draft Guidance & Insights
10/4/2022
First launched in Feb. 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.
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Data: The Future Of Regulatory Info Management In Europe
10/3/2022
The answer to many of our COVID-related real-world challenges lies in greater data centricity supported by the adoption of new technologies, and life sciences companies must play their own part in driving change.