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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Document 9286/25. In these cases, traditional clinical trials remain indispensable for ensuring patient safety and product efficacy.

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Preparing for a new era in the rare disease sector

European Pharmaceutical Review

1 Following the current trend, there has been a significant rise in the number of documents mentioning both artificial intelligence (AI) and rare diseases. For documents published in 2014 this number was just six; in 2024 it was 157 ( Figure 2 ). 1 Figure 1 : Documents by year. 1 Figure 1 : Documents by year.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events.

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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Syner-G

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Category: Regulatory Affairs , Drug Development Consulting.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. The worldwide trend of using botanical drugs and strategies for developing global drugs.

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

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. According to a November 2024 GlobalData report, per-trial costs have risen steadily since 2014, with single country trials increasing by 2.9%