Quality Systems

The US Food and Drug Administration has released an implementation report on its Regulatory Science Initiative. The report outlines the agency's plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products, according to an agency press release.

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest

FDA to Hold Public Hearing on Biosimilars Legislation, And More.

The US Pharmacopeia released a statement this week that explains in more detail last January's recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28).

Company and People Notes: Novartis Settles with US Attorney's Office; Hospira Names VP, And More.

The reopened debate over embryonic-stem-cell research could stifle many other scientific pursuits.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

From disagreement to denial, being cordial about quality control can be challenging.

In light of compendial changes, representatives of the US Pharmacopeia and an industry consortium provide perspectives on cap and ferrule labels.

President Obama and HHS eye innovation and countermeasures to protect public health.

The EDQM inspection program helps to ensure the quality of APIs on the European market.

There are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.

Although the European Generic medicines Association (EGA) n has welcomed the European Commission's proposal for a Directive on the falsification of medicines, it has also identified subjects that are of specific relevance to the European generic medicines industry.

There are apparent inconsistencies between the use of these reference materials and the manufacture of the reference solutions that are actually used in the regulated test method.

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.