pharmaphorum

OCTOBER 11, 2022

In addition, RCTs don’t have to rely on two different data sources, which may have different operational definitions, assessment methods, and measurement timing. Documentation of detailed descriptions of the ECA population is critical, including the mechanisms and conditions that led to the patients being recorded in the data source.

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FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Documentation Adverse Reactions Communication Drug Development 105

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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Drug Development Biosimilars Documentation Labelling 103

Syner-G

MAY 4, 2022

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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Documentation Drug Development Communication 52

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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Drug Development Documentation 52

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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Drug Development Documentation Labelling Medical Records 64

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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Documentation Communication Pharmaceutical Manufacturing Labelling 52