Quality Systems

In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.

To fund expanded FDA operations designed to streamline drug development and approval, FDA and industry representatives have negotiated the Prescription Drug User Fee Act III.

Following a step-by-step approach to software development involves planning, analysis, construction, and implementation.

A new set of proposed GMP standards for excipents may present more problems than benefits.

Brand and product security technologies offer pharmaceutical manufacturers anticounterfeiting solutions.

FDA cites manufacturing difficulties as a main contributing factor to recent drug shortages, which mainly involve injectibles and vaccines.

Near-infrared spectroscopy is a sophisticated and selective technique that has emerged as a powerful tool for the analysis of pharmaceuticals.

Proposed funding increases for FDA reflect plans to significantly increase user fees collected from manufacturers under the Presciption Drug User Fee Act.

This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.

FDA's Center for Drug Evaluation and Research is driving efforts toward creating initiatives to streamline regulatory processes, speed up drug production, and reduce costs.

Participants at a Pharmaceutical Research and Manufacturers of America workshop share their views about the acceptable analytical practices of conducting forced degradation studies.

Pharmaceutical companies will face a number of issues and challenges this year that will affect their resources, operations, and the markets they serve.

Anthrax contamination has put pharmaceutical quality and supply issues on the front page, along with patent and pricing policies.

Batch SCADA systems are assessed for regulatory compliance and functionality.

FDA may adopt new requirements to enhance the safe use of pharmaceuticals and ensure that all US drugs are available when needed.

Providing prescription drug benefits for senior citizens is a pressing issue for Congress, pharmaceutical manufacturers, pharmacies, and ultimately the beneficiaries of proposed plans.

The authors forecast how the current industry events and trends will affect computer validation in the future.

The Center for Drug Evaluation and Research is adopting new approaches to how it oversees the development and approval of new drugs and how it ensures the safe use of prescription drugs by the public.

USP ensures the microbiological quality of products by way of the development, proposal, and acceptance of general information chapters.

Current events and trends in regulations, business practices, and technology forecast the future of computer validation.

Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.