Quality Systems

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The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.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The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an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).

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee?s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress.

Also, AstraZeneca announces changes to its supply chain operations; Christian Velmer appointed head of Wyeth Canada; More...

The European Commission (EC) published a preliminary report stating that competition in the pharmaceutical industry does not work as well as it should.

When accusations fly: 'Tis better to give than to receive.