Regulatory Oversight and Compliance

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.

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.

The US Food and Drug Administration published a Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format in the Federal Register on July 11.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

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

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

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.

The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research will begin indexing structured product labeling in the product labeling for human drug and biologic products.

Comparative-effectiveness analysis aims to promote appropriate pharmaceutical spending.

With counterfeiting on the rise and Europeans worried their backyard is becoming a base for such illegal activity, legislators have proposed a series of solutions that span the continent and abroad.

Regulators face demands to improve postmarket surveillance and meet review deadlines.

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

Heparin contamination casts a shadow on regulatory oversight of product quality.

Quality-by-design submissions may reduce supplements and improve change management.

The US Food and Drug Administration released a final guidance on protocol for testing sterile products.

The rise in overseas manufacturing undermines FDA oversight of drug quality.

A wave of pharmaceutical expansions is expected in Europe this year, surprisingly by Indian companies.

The US Food and Drug Administration approved 69 new drug applications last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily.

The US Food and Drug Administration released a draft plan for modifying its information technology infrastructure. The plan follows the renewal of the Prescription Drug User Fee Act (PDUFA IV).

As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.

To keep up with applications, FDA promotes new testing and administrative methods.

New FDA act reshapes drug development and marketing to restore public trust in pharmaceutical regulation.

The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.

The US Food and Drug Administration launched a new program to increase the number and variety of generic drugs available to the public, beginning in FY2008.

Expanded access to drugs for seniors has increased demand and focused attention on costs.

The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.