2017 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).
pharmaphorum
APRIL 27, 2021
Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.
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Express Pharma
AUGUST 10, 2024
Divergent regulatory requirements between NDCTR 2019 and Medical Device Rules 2017; between NDCTR 2019 and biologics guidelines; and the need for animal studies for approved new drugs with modified or new claims would make the regulatory process time-consuming and costly for a startup.
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.
pharmaphorum
OCTOBER 29, 2020
By 2017, NICE added the Preliminary Independent Model Advice (PRIMA) service. 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 service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE.
European Pharmaceutical Review
JULY 4, 2024
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.
Syner-G
APRIL 27, 2023
Once a drug or biologic has been granted orphan drug status, Sponsors may be eligible to receive benefits such as tax credits for some of their clinical trials or qualified clinical testing costs, a waiver of the prescription drug user application fee, and may be eligible for seven years of marketing exclusivity upon product approval.
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