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Transitioning to eCTD v4.0

The Premier Consulting Blog

offers significant advancements in the way that sponsors and regulatory bodies handle submissions, and adapting to these improvements will be mandatory across all major regulatory authorities by 2028 (earlier, in many regions). Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions.

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Analysis Chemical Thank You California publishes draft regulations for landmark plastic pollution reduction act

Agency IQ

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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Highs and lows of drug repurposing 

Drug Discovery World

According to MarketWatch, the drug repurposing sector was thought to be worth $25,280 in 2021 and is expected to grow to $30,620 million by 2028 with a CAGR of 2.8%. This level of growth is unsurprising for an industry which will always look to the latest opportunities to drive science. . Benefits and barriers . Global efforts .

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Article EMA Thank You New MDR/IVDR standardization request adds standards, moves deadlines

Agency IQ

To support the extension, the request also noted the extended transitional periods for medical devices and diagnostics though December 31, 2028. In the new standardization request, this standard has a deadline of 2024 for IVDR (Annex II) but 2028 for MDR (Annex I). Another discrepancy is the symbols standard, ISO 15223-1.

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Nine Key Takeaways from Dreamforce 2023

Perficient: Drug Development

jobs by 2028. This solidifies that Salesforce is leading the charge in AI, and Perficient is leaning into the partnership to bring innovative solutions to our clients. We learned about new Salesforce capabilities and technologies, heard new product announcements, and connected with peers and clients from across industries.

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Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

Applicants have until June 19, 2028 , “individually or collectively,” to submit the application to the assigned RMS ( Article 8 ). Finally, companies will then have until June 19, 2028 , to submit applications for approval of the work program-listed substances to the assigned RMS.

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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. The CORE-MD project contributed significantly to what clinical evidence for orphan and pediatric devices should look like.

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