Quality Systems

The authors describe the critical aspects of an ideal fermentation services provider.

The US Food and Drug Administration will hold a public hearing Oct. 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use.

FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval applicatin (PMA).

The US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil.

The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use.

The concept of the the triple bottom line incorporates a company's financial, social, and environmental performance. As a result, an increasing number of companies are investigating how sustainable, green technologies and practices can help them stay competitive in a challenging regulated market.

Decontaminating pharmaceutical manufacturing facilities is essential for producing safe and pure drugs. The most commonly used decontaminant in the industry has been sublimated formaldehyde.

The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

The US Food and Drug Administration seeks contractors that will identify, describe, and evaluate potential data sources or data environments that could participate in the agency's Sentinel Initiative.

Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

The US Food and Drug Administration released its user fee rates for fiscal year 2009 last Friday.

The pharmaceutical industry?s outsourcing practices receive increased attention as Congress evaluates the role of outsourcing in drug-safety issues.

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

Myth versus Reality: What does Q10 implementation really mean for my company?

Surrounded by competition, Vietnam's 2020 vision focuses on building a biotech sector worthy of its Asian neighbors-as well as the growing global biopharmaceutical market

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

USP's guideline for pending monographs can speed up publication of monograhs and time to market.

The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.

FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.

After five years in the making, the official pharmaceutical quality system is here. All three parties to ICH adopted a final version of Q10 and agreed to implement the guideline through their individual regulatory bodies.

Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.

The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.

The European Medicines Agency recommended strengthening the warnings for oral moxifloxacin medicines and concluded that these drugs should only be prescribed to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia when other antibiotics cannot be used or have failed.