Agency IQ

MAY 28, 2024

This draft framework – which will come into force alongside the future medical device regulations – proposes four market access routes that have the potential to recognize the decision-making of four “comparable regulator countries,” but only for certain device and diagnostics types. law as the Medical Devices Regulation 2002 (UK MDR 2002).

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The Premier Consulting Blog

NOVEMBER 20, 2023

Clinical development experts would need to navigate the potential complexities arising from this regulatory shift, particularly in terms of trial design and evidence generation. Our expertise gives us the ability to develop customized and tailored strategic plans, mitigate regulatory risks, and optimize marketing success.

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. A Phase 3 trial is ongoing.

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The Pharma Data

JANUARY 25, 2021

Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time.

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Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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Agency IQ

JANUARY 26, 2024

EMA regulators themselves published an article discussing the review process for companion diagnostics and the lack of opportunity to use a single submission for the drug clinical trial under the Clinical Trial Regulation and the performance study application according to the IVDR.

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Agency IQ

FEBRUARY 2, 2024

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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The Pharma Data

NOVEMBER 4, 2020

Amarin’s decision to continue to invest in expanding the market for VASCEPA also reflects its confidence in its manufacturing processes, which the company has built over a decade to achieve consistent, high-quality, stable supply to support anticipated global demand. commercial team.

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The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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