Regulatory Articles

Califf Sidesteps Drug Pricing Complaints from Senate

Nov 18, 2015

By Jill Wechsler

Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.

Pressure Mounts for Greater Clinical Trial Data Transparency

Nov 17, 2015

By Jill Wechsler

Large pharma companies have fallen “below legal and ethical standards” for making public information from the relevant clinical trials, according to a report from Bioethics International.

6 Reasons Why Your Drug Could Be Put on Clinical Hold

Oct 02, 2015

By Applied Clinical Trials Editors

In this article, Characteristics of a Successful IND, IDE the author discusses ways in which your drug or device could be put on hold.

Characteristics of the Successful IND or IDE

Sep 17, 2015

By Brian D. Bollwage, JD

Tips for avoiding a clinical hold.

Redefining the Sciences of Drug Safety

Aug 26, 2015

By Dr. Magalie Emile-Backer

Innovative surveillance tools and technologies have transformed the field of drug safety into a more proactive, dynamic analytical process.

Regulatory News

ACRES Integrates eAdjudication into Shared Platform

Ethical GmbH’s Ethical eAdjudication® Platform will be included in ACRES’ shared global platform of integrated technologies.

FDA’s CDER Chooses MasterControl as QMS Provider

CDER’s Division of Pharmaceutical Analysis (DPA) will be adopting MasterControl’s full QMS to manage documents, training records, audits, CAPAs, change control, and other quality processes.

FDA Looks to Limit Clinical Trials in Biosimilar R&D

This scenario seeks to limit animal and clinical studies to only those needed to eliminate residual uncertainty about product performance. Although innovators maintain that clinical trials still are needed to fully examine immunogenicity and other unique attributes of proteins and monoclonal antibodies, biosimilar developers look to extensive product characterization and to pharmacokinetic (PK) or pharmacodynamic (PD) studies to address these concerns.

ICH GCP Goes Risk Based

In this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.

New Drug Safety Alliance, Website to Educate on REMS

The Patients Alliance for Drug Safety Protections is comprised of 20 public health, patient advocacy, health professional and disease organizations. To underscore the value of REMS to public health, the Alliance unveiled a new online resource.

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