Quality Systems

The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.

FDA launches BeSafeRx program and releases guidance for industry.

EMA has been increasing its interactions with other regulatory agencies across the globe. The agency's most talked about collaboration is with FDA, but EMA has also been intently focused on bolstering its relationship with its counterparts in Japan, India and Russia.

The European Medicines Agency has abolished its Cell-based Product Working Party and Gene Therapy Working Party, with the aim of improving efficiencies and optimizing the use of available expertise.

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicolored brain that appeared on the company's website for the diagnostic PET tracer, Amyvid.

USP Hosts Symposium on Science and Standards

Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

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.