Quality Systems

Generic-drug manufacturers are preparing to pay fees to FDA for the first time in the agency’s history.

The European Medicines Agency has launched a public consultation concerning its inventory of pediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

The European Commission remains vigilant in monitoring potential pay-to-delay deals.

International trade can be great for business, but breaking border laws can put one in hot water.

Identifying and classifying rouge can help to determine CAPA.

USP optimizes identification tests and impurities procedures.

Import controls and risk strategies aim to promote quality and spur new drug development.

Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.

MIT survey results address product and site characteristics that statistically correlate with quality performance.

Regulators in both the EU and the US have attempted to stimulate paediatric-drug development with incentives offering extended periods of patent protection, but are these actions having the desired effects?

Policymakers must balance fundamental issues involving access to medicines and pricing.

This article presents an overview of ISPE's guide on project management.

The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms and APIs of generic drugs.

The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

Regulatory Roundup: ISPE issues ozone sanitization guidance and EMA amends incident management plan

Manufacturers willing to report bad news about the supply can help reverse the shortage trend.

After a series of government reforms that are appealing to both domestic and foreign players, the Japanese pharmaceutical market is making a comeback.

The author discusses strategies for preventing cargo theft.

Import controls and risk strategies aim to promote quality and spur new drug development.

The authors compare direct combustion with rinse and swab sampling methods.

The author discusses how to manage pending pharmacopeial changes.

No matter the upside or downside to the Affordable Care Act, there's work to be done.

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.

New law provides FDA with the resources it needs to safeguard drug supply chain.

Meticulous system configuration can prevent machines from taking over.

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.