European Pharmaceutical Review

JULY 4, 2024

It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product. The worldwide trend of using botanical drugs and strategies for developing global drugs. BMB Reports. 2017;50(3):111–6. Premier Consulting [Internet].

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Syner-G

APRIL 27, 2023

Obviously, the very nature of rare diseases means that the population of patients available to enroll in clinical trials is very small, and if there are other organizations with drug development programs targeting the same indication, competition for patients can be even more challenging.

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FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. the Confirmatory Evidence Guidance, available here ) had appeared on CDER’s Guidance Agenda for the past three years.

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Putting Patients First Blog

JUNE 26, 2025

11 The role of patient-centered evidence in the renegotiation process also requires greater definition. Rutta Chief Executive Officer 1 Centers for Medicare & Medicaid Services, “Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request,” Federal Register 90, no.

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Putting Patients First Blog

APRIL 7, 2025

At the same time, as insights generated by AI increasingly shape the selection of drug targets, biomarkers, or dosing strategies that inform regulatory submissions, it is essential that any AI-derived outputs used to support regulatory decision-making meet appropriate standards of empirical validation and scientific transparency.

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European Pharmaceutical Review

JANUARY 13, 2025

3 Encouragingly, there are many examples of the life sciences sector seeking to embrace sustainable drug development; reconciling the drive for innovation with the need to reduce waste and emissions produced during the R&D process, as well as throughout the product lifecycle. 5 However, the benefits are well documented.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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Putting Patients First Blog

APRIL 14, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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Pharmaceutical Technology

JULY 11, 2025

The present clinical trial ecosystem is not equipped nor projected to have the capacity to satisfy this demand, and as a result the ecosystem is facing a potential slowdown in drug development. Rare disease trials, by definition, struggle with small patient pools scattered across the globe. Sign up for our daily news round-up!

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pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. What I’ve seen with patient centricity over the last few years is really a broadening of the definition,” Dr Mullen explained. But who is benefitting?

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Express Pharma

OCTOBER 31, 2024

She highlighted that while the GCC was initially set up for cost savings in drug development, the focus has shifted to harnessing India’s vast talent pool, particularly in the scientific and medical fields, in an interview with Viveka Roychowdhury India seems to have become a hub for pharma GCCs. With a long gestation period.

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