Quality Systems

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

Companies exhibit developments for pharmaceutical packaging to meet needs, such as e-pedigree and inspection requirements.

The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China.

Agencies collaborate to ensure consistent product quality.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

The guidance describes a risk-based approach to monitoring of clinical trials.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

The US Supreme Court's Myriad decision satisfied both patient groups and patent holders

Siegfried Schmitt of PAREXEL explains how regulatory agencies are getting serious about inspections.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.

Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.

The bio-pharmaceutical business outlook in South Korea remains positive.

FDA funds research to further development of innovative generics, while working to address review and approval issues.

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers to better secure the pharmaceutical supply chain.

Increased pharmaceutical trade creates new challenges for regulatory oversight.

Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.

The precautionary recall follows manufacturing deficiencies identified at the site in India.

Europe prepares for inclusion of Croatia in EMA activities.

Programs assist in the fast track of drugs for serious conditions.

Brazil offers opportunities and challenges for global pharmaceutical companies.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

David Elder, vice-president, technical at PAREXEL, discusses the best way to productively participate in a regulatory meeting with FDA.

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.