Quality Systems

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Compliance with the new traceability requirements necessitates an understanding of how and when to begin implementing changes in an ever-evolving industry.

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

Pharma can boast of big-picture successes, but needs to work on operational issues.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

A complex and evolving set of regulations challenges drug manufacturers to understand and implement serialization requirements.

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

Pharmaceutical companies should take into consideration intellectual property protection when outsourcing the packaging of their products.

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.

The agency has recommended granting marketing authorization for Opdivo.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

FDA grants Pfizer Breakthrough Therapy designation for its treatment of ROS1-positive non-small cell lung cancer.

Serialization experts will share best practices and practical applications at INTERPHEX 2015.

The European Medicines Agency releases findings from marketing authorization application analysis.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

WHO says that results from clinical trials should be reported within 12 months of completion of the study

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.