Quality/GMPs

Video with Paul Pluta

Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

New FDA supply chain policies aim to strengthen inspection and oversight processes.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

EMA publishes reflection paper on issues regarding the parenteral administration of coated nanomedicines.

FDA receives adverse event reports related to calcium gluconate infusions.

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.

FDA releases FY 2014 generic-drug user fees.

EMA restructures organization.

EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.

The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.

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.

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

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

Europe prepares for inclusion of Croatia in EMA activities.

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

Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.

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

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.