Struggling to understand the FDA regulatory requirements and procedures for SPF testing? Curious what claims you can test your SPF products for? Come join our June 3rd webinar hosted by our Photobiology Team Lead, Dominique Sawyer, and Photobiology Manager, Chelcie Mejia. Click here to save your seat today: https://lnkd.in/ghzuHAzf
Eurofins | CRL, Inc.’s Post
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Recalls in the medical device sector are usually initiated when a significant risk is identified, either by the manufacturer or a regulatory body such as the FDA or MHRA. These risks might range from device malfunctions to non-compliance with evolving standards. 👁 Effective communication is key during a recall, with clear instructions on necessary actions to mitigate risks. 🔑 to learn more, visit our webstie 👉 qreg.co.uk
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Having to keep up with updates to SEND guidelines can be tough. In this webinar, our expert Audrey Walker discusses 2023 updates to SEND guidelines and the current submission requirements for the CDER and CBER divisions within the FDA. https://okt.to/N81dz4
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Assisting to connect biotech and pharma companies with nonclinical experts to help advance new therapies.
Having to keep up with updates to SEND guidelines can be tough. In this webinar, our expert Audrey Walker discusses 2023 updates to SEND guidelines and the current submission requirements for the CDER and CBER divisions within the FDA. https://okt.to/IwZoc5
Understanding SEND: Ensure Your Dataset Complies with the 2023 Updates
criver.com
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VP of Commercial at DeciBio | Precision Medicine Venture, Strategy Consulting, Market Intelligence | Strategic Advisor at Women in Bio | Member at HBA Los Angeles
Next week! Join us live for our upcoming webinar on FDA LDT regulation. I'm excited to host this one with so many of the industry's brightest. When? Tuesday, April 23, 2024 at 09:00 AM PT Register Here https://lnkd.in/gpWUFpNG Share your questions below! #PrecisionMedicine
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The following webinar by US-FDA shall describe the ongoing efforts to modernise the 501K pre-market notification submission of Class-II medical devices, specially selecting the predicate device and determinig the need for clinical evaluations is worth to learn. Please add to your calendar if you would like to learn more about 3 new draft guidances related to 501K program. https://lnkd.in/gcX8irQe
On October 26, 2023, at 1:00 p.m. we will host a webinar for industry and other interested stakeholders to share information on CDRH’s ongoing efforts to modernize the 510(k) Program. During the webinar, the FDA staff will provide an overview of and answer questions about three new draft guidances related to the 510(k) program. https://lnkd.in/eR9aY_ck
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Accelerate your time-to-market for products treating serious conditions or unmet medical needs by understanding FDA Expedited Pathways ⏩ Access the infographic to learn about the six different FDA expedited programs and designations👇 🔷 The benefits 🔷 Qualifying criteria 🔷 Timing and procedures https://bit.ly/3UI13rm #FDA #FDAExpeditedPathways
FDA Expedited Pathways
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The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.
New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA :: Parexel
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The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.
New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA :: Parexel
share.parexel.social
