Regulatory Oversight

The two agencies have set up a working group on involving patients in drug development.

The agency provides quality, development, manufacturing, and labeling recommendations.

Computerized systems can solve some of the data integrity problems with conventional paper-based systems.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.

Pharma has voiced strong opposition against Britain’s departure from the EU.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.

The agency holds a workshop to strengthen collaboration with healthcare providers.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.

PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.