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What is the largest CRO in the US?

Vial

By geographical region, the global CRO services market in 2023 was dominated by North America. Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market.

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Article EMA Thank You Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

Agency IQ

This database was created to share post-market surveillance information across E.U. Ultimately, this module will interact with CTIS , the drug clinical trial information system. But if usage weren’t mandatory until halfway through 2029, which is five years from now, it won’t be useful for tracking this for some time.

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BridgeBio Pharma, Inc. Prices Upsized Offering of $650 Million Convertible Senior Notes

The Pharma Data

Nasdaq: BBIO) (the “Company,” “we” or “BridgeBio”) announced today the pricing of $650 million aggregate principal amount of 2.25% convertible senior notes due 2029 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).

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Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

Agency IQ

MDR Article 78(14) sets out the original transition deadline in going from voluntary use of the coordinated assessment process to mandatory use as May 25, 2027; for IVDs, use of the coordinated procedure becomes mandatory in May 26, 2029 for all Member States, as set out in IVDR Article 74(14).

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Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

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