Pharma’s ‘No-Show’ At Regulatory Meetings In India: Who Loses?

Regulators in India routinely face flak over lengthy approval timelines, but drug firms failing to show up at pre-scheduled regulatory meetings does little to improve the situation. The reason for the no-shows is open to speculation. Absenteeism appears to be significant in areas such as oncology and hematology.

Chairs
DRUG FIRMS FAIL TO SHOW UP AT REGULATORY MEETINGS IN INDIA

Pharmaceutical companies in India are failing to turn up at pre-scheduled regulatory meetings pertaining to clinical trial-related applications – on a fairly regular basis in some instances.

More from Review Pathways

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By 

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

More from Pathways & Standards

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By 

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By 

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.