Regulatory Oversight and Compliance

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

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.

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.

Biomedical innovation legislation may stall in 2016.

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.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

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 extends the indication of the drug in combination with bendamustine.

The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.

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The agency publishes draft guidance on assay development and validation for immunogenicity testing.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

The agency published guidance on data integrity as it is relates to CGMP compliance.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

FDA’s breakthrough drug initiative is more popular and successful than ever.

The agencies detail the results of their three-year collaboration.

The Office of Generic Drugs highlights the agency’s work to advance generic drugs.

The agency issues safety guidance to minimize medication errors relating to product design and container closure design.