Regulatory Articles

CDISC Standards Key to Meeting FDA Regulations, Research Goals

Oct 14, 2016

By Jill Wechsler

The deadline looms for new FDA requirements that all applications for new drugs and biologics compile and submit clinical trial data electronically. Meanwhile, efforts by the Clinical Data Interchange Standards Consortium (CDISC) to develop consensus-based standards for collecting data are not going unnoticed.

Digital Transformation of SAE Data Capture in Clinical Studies

Sep 20, 2016

By Dr. Andrew Rut

Processes for collecting data of serious adverse events (SAEs) and events of special interest (ESI) during clinical trials have been underwhelming for sponsors. Improving these processes using the latest digital advances can result in more complete analyses and more effective decision-making.

GCP Goes Mobile

Aug 01, 2016

By Moe Alsumidaie

Clinical trial noncompliance is an industry concern that persists today resulting in 483s being charged to study sites. Bill Tobia discusses his recently developed “No 483 for Me” app for helping study sites avoid common noncompliance practices during clinical trial conduct.

EMA’s New Tool: PRIME

Jun 13, 2016

By Emma Beausang, PhD

In response to the debate over allowing patients timely access to new therapies and ensuring safety, the EMA launched the PRIority MEdicines (PRIME) scheme in March. The aim of this initiative is to build upon existing regulations in Europe to support product development in cases of unmet medical need.

Regulatory Approval in India: An Updated Review

May 04, 2016

By Chirag Shah, Param Dave, MPharm

Issues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.

Regulatory News

FDA Highlights “Flexibility” in Approving Rare Disease Therapies

The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development. The challenge now is to see if confirmatory trials show more benefit, or lack of efficacy.

Calvo Elected for Second Term at EMA

Dr. Gonzalo Calvo has been re-elected by the Healthcare Professionals’ Working Party (HCPWP) of the European Medicines Agency (EMA) as its co-chair.

Regulatory Pros Spend More Time on Strategy

RAPS survey finds most regulatory professional have multiregional or worldwide responsibilities and are spending more time on strategic activities.

TrialScope Adds Four New Customers

TrialScope announces the addition of four new customers who have all contracted for PharmaCM, TrialScope’s SaaS-based clinical trial disclosure platform.

ICH GCP Guideline ‘Can Stay Relevant for 20 Years’

A statement issued by the European Forum for GCP (EFGCP) states that provided further updates are made, the ICH guideline for Good Clinical Practice (E6) can stay relevant for another 20 years.

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