Quality Systems

The US Food and Drug Administration sent Warning Letters to Bayer HealthCare (Morristown, NJ) about the company's "Bayer Women?s Low Dose Aspirin + Calcium" and "Bayer Aspirin with Heart Advantage" over-the-counter (OTC) products.

This position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.

Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles.

Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.

The Indian government may soon monopolize its pharmaceutical industry to cut costs and improve healthcare, but the move is sounding off alarm bells with the companies whose drug products are under review.

The US Food and Drug Administration seeks to understand nanotechnology better and exercise appropriate oversight over products that incorporate it.

Pharma companies could benefit from the lessons learned in this fall's financial crisis.

Production problems come in all shapes, sizes, and ... species.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

Scott Sutton discusses the current state of USP ‹1117› and USP's plans for future revisions.

During the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.

The US Government Accountability Office (GAO) released a report last week that examines and provides recommendations for the US Food and Drug Administration's foreign inspection process, including the agency's data management, inspection frequency, and oversight of problems identified during inspections.

The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations.

Pfizer and Lilly recently resolved issues related to their marketing practices for certain products.

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), chairman of the Oversight and Investigations Subcommittee, sent letters to the US Food and Drug Administration, Shaw Science Partners, and EthicAd to request information about a new FDA website.

According to a July 11, 2008 memorandum posted by the Center for Biologics Evaluation and Research, starting Oct. 15, Health Level 7 structured product labeling in XML (extensible markup language) will be the only acceptable presentation in electronic format for the submission of content of labeling that CBER can process, review, and archive.

FDA has completed its labeling updates to fluoroquinolone antimicrobial drugs.

During the past several months, Pharmaceutical Technology has been covering the US Food and Drug Administration's rulemaking on over-the-counter (OTC) cough and cold medications for children.

At a public meeting, the Medicare Payment Advisory Commission (MedPAC) discussed its recommendation that Congress establish a national database to publicly reveal financial relationships between physicians and the pharmaceutical industry.

John Dingell (D-MI), chairman of the US House Committee on Energy and Commerce and Bart Stupak (D-MI), chairman of that committee's Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA's process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company.

The lack of appropriate financial resources for the US Food and Drug Administration's growing global agenda has been a pertinent topic of late?and now appropriate staffing has become a large concern.

A bill that would require country-of-origin labeling for active and inactive ingredients for all prescription and over-the-counter pharmaceuticals was introduced in the US Senate last week.