Quality Systems

The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

An integrated information technology environment can help pharmaceutical companies find new processes and approaches to improve manufacturing efficiency, productivity, and quality.

A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products comply with the relevant statues and regulations of the United States throughout a product's lifecycle.

The US Food and Drug Administration announced that it had filed a Consent Decree on Dec. 23, 2008 and was awaiting the court?s entry of a permanent injunction that bars Actavis (Hafnarfjordur, Iceland), its officers Sigurdur Oli Olafsson and Douglas Boothe, and its subsidiary Actavis Totowa (Totowa, NJ) from manufacturing and distributing drugs at the Actavis Totowa facilities.

Frank Torti, currently principal deputy commissioner and chief scientist of the US Food and Drug Administration, will take over as FDA's acting commissioner next week, according to an official with the US Department of Health and Human Services (HHS).

Also, Novozymes Biologicals settles pollution case with the US Department of Justice; EntreMed restructures management team; more...

The generic-drug manufacturer Actavis reached an agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company?s US subsidiary Actavis Totowa LLC.

Although its domestic market is on the rise, Pakistan's market conditions have not proved welcoming enough to keep foreign investors.

The incoming administration has renewed hope for stem cells, but less adequate copycats may follow.

After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region's short- and long-term role? This article contains bonus online-exclusive material.

The authors propose that a postapproval management plan can serve as a tool to apply science- and risk-based approaches to the manufacturing process.

The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.

Will more resources and new leadership fix FDA, or is a major overhaul in order?

The authors propose an approach for qualification-target selection and show how it can be applied to blister-filling and packaging systems.

Instead of hampering progress, cost pressures might inspire Big Pharma to get creative.

President Obama's choice for agency leadership should take into account several factors.

Readers give advice on their best approach to handling (batch) rejection

Also, Crucell and DSM announce deals with GSK, Talecris, and CSL; Nobel Prize winner Luc Montagnier joins Viral Genetics; more...

The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

The US Food and Drug Administration dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Maryland.

The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted measures to strengthen its Guiding Principles for Direct to Consumer (DTC) Advertisements about Prescription Medicines.

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

The European Commission issued proposals last week to improve Europe's pharmaceutical market and patient safety.

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

President-elect Barack Obama officially nominated former Senator Tom Daschle as Secretary of Health and Human Services and named him the Director of a new White House Office on Health Care Reform late last week.

A surprising amount of the discovery and development life cycle is still based on manual and disconnected process steps.

Also, NicOx and DSM make manufacture and supply pact for naproxcinod drug substance; NovaRx appointed Norrie Russell president and COO; more...

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

The Environmental Protection Agency is proposing to add hazardous pharmaceutical wastes to the Universal Waste Rule to provide a system for disposing of hazardous pharmaceutical wastes.

The Synthetic Chemical Organic Manufacturers Association (SOCMA) has raised concerns over requirements for security vulnerability assessments (SVA) under the US Department of Homeland Security's (DHS) Chemical Facility Anti-Terrorism Act Standards (CFATS).