Quality Systems

It?s been a busy few weeks at the European Medicines Agency (EMA), with a number of marketing authorization suspensions and safety reviews launched, including a thorough review of all bisphosphonate-containing medicines following a possible increased risk of atypical stress fractures.

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality.

Pharma companies must ensure that patients have access to "objective, unbiased information" about medicines, according to MEPs of the European Parliament?s Health Committee — this should be a patient right rather than an option for pharma companies.

A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

The European Medicines Agency and the US Food and Drug Administration announced their individual regulatory decisions and resulting actions regarding the marketing of GlaxoSmithKline's (London) Avandia (rosiglitazone), a thiazolidinedione used to treat Type 2 diabetes.

EMA Reviews Drug Marketing Authorization Applications, And More.

Novartis Sells US Enablex Rights; Ricerca Names Chemistry Director; And More.

Amgen (Thousand Oaks, CA) issued a voluntary recall last week of certain lots of Epogen(R) and Procrit(R) (Epoetin alfa) vials.

USP to Make Pharmacopeial Forum Free Online, And More.

DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.

The European Medicines Agency (EMA) and the US Food and Drug Administration have extended their confidentiality arrangements for human and veterinary medicinal products.

US Food and Drug Administration Commissioner Margaret A. Hamburg spoke at the Generic Drug User Fees Public Meeting last Friday, Sept. 17, 2010, about enacting user fees for the generic-drug sector.

The US Food and Drug Administration recently issued a Warning Letter to Bristol-Myers Squibb (BMS, New York) for violations of current good manufacturing practice at the company's Manati, Puerto Rico, manufacturing facility.

The European Medicines Agency (EMA) has discussed the possibility of a global framework for clinical trials at an international workshop, given the fact that the majority of clinical trials for medicines approved in Europe are conducted outside of the EMA's regulatory reach.

Genzyme Sells Genetics Business; Bausch and Lomb Names Vice-President; and More.

ISPE to Hold Risk-MaPP 2010 Conference

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

The US Food and Drug Administration launched last week a performance management system designed to advance President Obama's commitment to transparency, public participation, and governmental collaboration.

The Society for Chemical Manufacturers and Affiliates (SOCMA) issued recommendations relating to disclosure of confidential business information (CBI) in response to Environmental Protection Agency's (EPA) decision to limit CBI claims on chemical identity under the Toxic Substances Control Act (TSCA).

ICH to Hold Training Workshops for Quality Guidelines

Weighing the pros and cons of REMS for bringing risky products to market.

Company and People Notes: Lonza Acquired Vivante; PPD Appoints VP of Quality Management; And More.

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.

Pending legislation may give FTC the authority to regulate all Hatch-Waxman settlements.