European Pharmaceutical Review

JULY 13, 2023

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.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

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.

Documentation 52

Documentation Drug Development Communication 52

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.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

FDA Law Blog: Biosimilars

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Documentation 59

Documentation Vaccines Drug Development 59

Putting Patients First Blog

FEBRUARY 6, 2024

The price of progress: funding and financing Alzheimer’s disease drug development. autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., Patient and public perspectives on cell and gene therapies: a systematic review. and Kumar, P.

Communication 40

Communication Documentation Drug Development 40

European Pharmaceutical Review

FEBRUARY 28, 2025

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.

Documentation 88

Documentation Drug Development 88

FDA Law Blog: Biosimilars

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

Drug Development 105

Drug Development Documentation 105