Perficient: Drug Development

MAY 30, 2024

.” – Mike Porter Top Trend: Transformation, Modernization, and Mandates LinkedIn | Blogs The health insurance industry is constantly changing, driven by the pressures it faces from customers, regulators, and market forces. I’ve been in this industry for over 20 years and I always want to keep learning!

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Regulations Science Marketing 88

Perficient: Drug Development

DECEMBER 27, 2023

Once published by regulators, Perficient’s Risk and Regulatory CoE will be here to walk our clients through the changes. YOU MAY ENJOY: Regulatory Reporting in Financial Services Modernizing CRA Regulations Managing compliance risk frameworks in alignment with existing risk profiles is crucial as customer needs evolve.

Compliance 52

Compliance Regulations Production 52

Drug Target Review

JULY 4, 2023

The global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026. 1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Antibody drug conjugated with cytotoxic payload.

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Small Molecule Drugs Clinical Pharmacology Trials 145

Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. There are several high-level takeaways from these updates for drug developers.

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FDA Laboratories Regulations Clinical Trials 40

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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FDA Science Regulations Biosimilars 40

The Pharma Data

MAY 15, 2023

Development of the biosimilars will ramp-up over the coming 12-18 months.” Just – Evotec Biologics has developed an optimized proprietary ecosystem for cost-efficient, state-of-the-art drug development and manufacturing. Work is set to begin this year, with full operations provisionally planned for late 2026.

Biosimilars 40

Biosimilars Production Government Clinical Trials 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The study is planned to begin in 2026 and conclude in 2028.

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FDA Trials Regulations Therapies 40