Quality Systems

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

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.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

FDA Provides Information On Advisory Committees, Announces Public Meetings, And More.

Software and online monitoring are helping the pharmaceutical industry improve its corrective and preventive action programs. This article contains bonus online material.

To properly inspect based on measurement, a reference standard is crucial for comparison.

PharmTech talked to anticounterfeiting experts to discuss terrorism as a source of counterfeit products.

New data provide insight into pharma-industry professionals' daily lives.

The President's Council on Advisors on Science and Technology (PCAST), a group administered by the federal Office of Science and Technology Policy (OSTP), issued recommendations to improve the country's ability to accelerate vaccine production and delivery in the event of a pandemic flu outbreak.

The author explains the background behind the excipient pedigree and how to implement its use.

India has evolved from a low-cost region to an area with extensive technical capability and high quality standards.

When assessing the competencies of an outsourcing service provider, sponsor companies must pay a great deal of attention to the cGMP compliance level of the provider.

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius released last week an examination of the federal government's system to produce medical countermeasures, or medications, vaccines, equipment, and supplies needed for a health emergency.

Regulatory Roundup: PDUFA Fees Published, And More.

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

Commissioner Hamburg Says China is Improving Export Regulation

Changing or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don?t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.

Novartis has been told off by the FDA in a letter about a social media Facebook widgit that appears on the company?s Tasigna website.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.