Quality by Design

The US Food and Drug Administration will have a $2.1 billion budget next year if the fiscal year 2009 bill markup by the US House of Representatives' Agriculture Appropriations Subcommittee passes through Congress.

The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1.

The California Senate passed SB 1096 on May 29, voting to amend the state?s Confidentiality of Medical Information Act to allow pharmacies to provide third parties with patient information for the purpose of mailing prescription refill reminders and drug information directly to patients.

The author provides an overview of key regulatory issues facing companies seeking to market their biopharmaceutical agents globally.

The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.

In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year plan under the Prescription Drug User Fee Act (PDUFA).

Senator Chuck Grassley (R-IA) sent a letter to Amgen (Thousand Oaks, CA) last week asking the company to account for the high rebates it has given to certain physician groups who bought Aranesp.

Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics.

Much to the surprise of most close observers of the Food and Drug Administration, Janet Woodcock agreed last month to resume control of the Center for Drug Evaluation and Research.

With another potential "made-in-China" crisis looming over the recall of heparin, critics and the media seem to be waiting in line to take another jab at the US Food and Drug Administration.

There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.

Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.

The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter use of Merck & Co.'s “Mevacor” (lovastatin) 20 mg.

Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.

The Interagency Working Group on Import Safety issued its action plan for ensuring the safety of imported products, including drugs, food, and consumer products, into the United States.

US Food and Drug Administration Commissioner Andrew C. von Eschenbach testified before Congress last week to outline the agency’s inspection process for foreign drug manufacturers and efforts to improve the agency’s information technology systems.

Medical students are participating in various activities this week to persuade medical schools to shield their campuses from the influence of pharmaceutical marketing as part of ?National PharmFree Week.?

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs. This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).

The US Food and Drug Administration’s Interagency Working Group on Import Safety released a Strategic Framework based on a cost-effective, risk-based approach for ensuring the safety of products exported to the United States.

A comprehensive book helps readers navigate the European drug-approval process.

FDA's long-awaited GMPs for supplements appear as food and drug safety concerns override lingering opposition.

Washington, DC (May 3)-The Biotechnology Industry Organization published a position paper stating that any legislation establishing a regulatory pathway for follow-on biologics should grant pioneering products 14 years of data exclusivity.

Rockville, MD (Apr. 5)-The US Food and Drug Administration concluded its reinspection of Wyeth?s manufacturing facility in Guayama, Puerto Rico. Conditions at the Guayama facility prompted a Warning Letter in May 2006.

Washington, DC (Feb. 7)-The Synthetic Organic Chemical Manufacturers Association (SOCMA) submitted comments to the US Department of Homeland Security in response to proposed DHS regulations on chemical site security, asking DHS to take into consideration the unique nature of the specialty batch manufacturing sector.

"Quality by design" (QbD) and "quality risk management" at long last seem to be moving from the buzzword stage to becoming important influences on drug development and manufacturing. A series of quality standards issued by the International Conference on Harmonization (ICH) is encouraging the adoption of common quality-based drug manufacturing approaches designed to reach the "desired state" of drug manufacturing (i.e., more efficient, agile, flexible operations that can reliably produce high-quality drug products with less regulatory oversight). These developments reflect increased pressure to make pharmaceutical manufacturing more efficient and less wasteful and to encourage regulators in all regions to focus on the most critical issues affecting product quality and patient safety.

The US Food and Drug Administration announced the creation of the Office of the Chief Medical Officer as well as two important staff changes at the agency.

Washington, DC (Dec. 7)-One of the last acts of outgoing Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration.

Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.

Liverpool, UK (Oct. 20)-Novartis Vaccines and Diagnostics Limited is recovering two lots totaling 500,000 doses of its ?Fluvirin? influenza virus vaccine after reports that the product had been received from distributor Cardinal Health Care in either a frozen state or below the required storage temperature range of 35?46 degrees F.