Regulatory Oversight and Compliance

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 steering committee of the International Conference on Harmonization and its expert working groups adopted Quality Guideline Q10 "Quality Systems" last week at a meeting in Portland, Oregon.

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.

The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council, held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union.

As part of a larger effort to address drug counterfeiting, the European Commission is seeking to tighten manufacturing and related supply-chain requirements for active pharmaceutical ingredients.

Comparative-effectiveness analysis aims to promote appropriate pharmaceutical spending.

Customers complaining lead to some serious explaining.

With rising drug deveopment costs and burdensome clinical trials, Indian-based firms are transferring their research departments to other entities in hopes of saving cash, mitigating risk, and ultimately, buying back the rewards.

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.

WFI system deficiencies and damp tax records cause problems for two plants

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.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

Essential components of a good inspection: good ingredients, proper inserts, and ... deer?

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.

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

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

A. Nair discusses patent disputes in India.

If not properly monitored, filters and plastic bags can keep back more than they should.

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

The US Food and Drug Administration posted on its website a Jan. 24 Warning Letter to Novartis Vaccines and Diagnostics.

FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.

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

If at first the product fails, then inspect, inspect again

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).