Regulatory Oversight and Compliance

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

FDA wants manufacturers to revise product labeling and packaging and step up adverse-event monitoring to reduce risky product use.

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.

Threats of bioterrorism generate new reulatory policies to protect the public against biological warfare.

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.

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

FDA's new initiatives for the safe use of prescription drugs try to balance manufacturers' concerns about increased regulations with a low-risk approach to patient safety.