2019 Documentation Drug Development 
FDA Law Blog: Biosimilars
APRIL 8, 2025
Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Leading FDAs implementationof the Drug Competition Action Plan (DCAP). 314.150(c).
European Pharmaceutical Review
SEPTEMBER 22, 2022
Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. Regulatory and payer guidance. Patel et al.
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pharmaphorum
AUGUST 19, 2022
Since DiMe’s launch in October 2019, there has been a 929% increase in the number of digital endpoints being used by the life sciences industry for the safety and efficacy of new drug development. The post Fuelling the efficiency of drug development through sensor data integration appeared first on.
pharmaphorum
OCTOBER 29, 2020
Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE. The NICE-CADTH service was launched in 2019. What is the impact?
Pharmaceutical Technology
FEBRUARY 8, 2023
In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.
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. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.
pharmaphorum
APRIL 27, 2021
Today (27 April), the ODAC is due to look at Tecentriq in combination with BMS/Celgene’s Abraxane (nab-paclitaxel) for people with advanced triple-negative breast cancer (TNBC) whose tumours express PD-L1, an indication which was provisionally approved by the FDA in 2019 on the strength of the Impassion130 study.
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