Quality/GMPs

FDA and EMA launch initiative to share bioequivalence inspection information.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

NPS Pharmaceuticals uses its expertise in development, regulatory compliance, and commercialization to bring to market products with orphan drug status.

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

OGD is under pressure to improve review operations.

EMA revises its polices on fee reductions for orphan drugs for 2014.

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

Variation understanding and modeling is a core component of modern drug development.

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.

Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R'D, clinical research, and market growth.

Criticality is used as a risk-based tool to drive control strategies.

The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

USP issues call for candidates for its 2015-2020 Council of Experts.

Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.

FDA releases guidance on pulmonary tuberculosis drugs.

EMA and FDA publish joint QbD guidance on design space verification.

A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

An effective supplier-initiated change management process is discussed.

A new report details FDA's role and responsibilities in personalized medicine.

New regulation offers patients in Brazil greater access to experimental drugs.

Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.