Regulatory Affairs Editorial
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How To Optimize Returns On Plain Language Summaries
10/31/2022
The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.
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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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Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations
10/14/2022
This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.
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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FDA’s RTOR Program: Draft Guidance & Insights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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Life Sciences RIM: Modernization & Moving Ahead
9/28/2022
Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.
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How To Take Full Advantage Of RWD Without Jeopardizing Privacy Laws
9/26/2022
Biopharma companies need personally identifiable information to aggregate and analyze valuable real-world data. However, in many countries, these details are protected by data privacy laws. The EU's EHDS regulation helps clarify the situation in Europe, but other regulatory authorities will also need to clarify and articulate their positions.
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EU Reg. 536/2014’s Expiry Label Requirement Forces Us Backward, Not Forward
9/14/2022
In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.
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5 Specifications That The FDA’s Diversity Plan Needs To Include
8/16/2022
In April, the FDA released a draft guidance on diversity plans to improve patient enrollment in clinical trials. Tigerlily Foundation believes the FDA's final guidance on the topic needs more teeth.