Quality Systems

Senator Sherrod Brown sent a letter to Richard T. Clark, president and chief executive officer of Merck (Whitehouse Station, NJ), to ask for information about the company's reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.

The US Food and Drug Administration issued a final rule on July 18 that exempts early Phase I investigational drugs from certain good manufacturing practice regulations.

Bristol-Myers Squibb (BMS) agreed to reduce the output of ozone-depleting refrigerants at several industrial facilities around the country to resolve violations of the Clean Air Act. The company's modifications will cost approximately $3.65 million.

Also, Roche to end HIV/AIDS research program, WuXi PharmaTech makes appointments, more...

The US Food and Drug Administration published a Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format in the Federal Register on July 11.

Pfizer has agreed to pay $975,000 in civil penalties to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Connecticut, according to a release by the US Department of Justice.

The US Food and Drug Administration is seeking volunteers from the pharmaceutical industry to participate in a pilot program involving the submission of quality information for biotechnology products.

The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.

The European Pharmacopoeia Commission adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control.

Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control.

A recent US government study shows that follow-on biologics are likely to have a favorable economic impact if proposed legislation authorizing a regulatory pathway in the US is approved.

After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 "Residual Solvents" is now official.

The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007.

President Bush signed H.R. 2642, the Supplemental Appropriations Act of 2008, which provides $150 million to the US Food and Drug Administration for medical-safety and drug-safety activities.

A new book explains process analytical technology, drug stability, and quality.

The year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.

The authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.

A growing preference for public-private partnerships is spurring innovation and technology among Dutch pharmaceutical companies.

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

They may have seemed harmless at first, but these ideas took a big bite.

Forums, blogs, and more can spark innovation.

Polyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.

With no economic relief in sight, industry, like all of us, is grappling with high-and new-costs.

New scientific discoveries promise to expand treatments for rare and neglected diseases.

Patient safety must be the primary concern of any validation effort. The author explains how a risk-based approach to validation and compliance follows naturally from this premise.

The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website.

Also, Stiefel Laboratories will acquire Barrier Therapeutics, Danube Pharmaceuticals appoints Brian Levy COO, more...

The US Food and Drug Administration will have a $2.1 billion budget next year if the fiscal year 2009 bill markup by the US House of Representatives' Agriculture Appropriations Subcommittee passes through Congress.

With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process.

Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.