Quality Systems

President Barack Obama's State of the Union address, delivered last week on Jan. 25, 2011, to the US Congress, was largely well received by the pharmaceutical and biotechnology industries.

The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.

FDA Holds Workshop on Orphan Drugs

Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.

Chemistry reviewers in FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs.

Follow-ons were all the rage at this year's JP Morgan Healthcare Conference.

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.

As biologic-drug patents move toward expiration in the US, Indian firms with experience in the follow-on biologics arena are eager to partner with global manufacturers and secure their place in the growing biosimilars market.

Legislation has hampered cross-border drug importation and limited choice.

Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

USP helps to improve drug quality in 32 countries.

Taking care to note, file and re-check information can save one from future mishaps.

Using risk assessment properly can provide industry with a unique tool for quality control.

Nearly six years after applying, the FDA joins the Pharma Inspection Co-operation Scheme.

How to adapt a real time release approach to powder processing during drug-product manufacturing.

The author describes why statistical significance would impose an unreasonable burden on manufacturers.

Innovations protect the quality of temperature-sensitive products.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

Johnson & Johnson's run of quality issues, recalls and other bad news continues with yet another product recall.

Merck Teams with Parexel; Roche CFO to Retire; and More

FDA Sets Limits for Acetaminophen in Prescription Combination Products

The EU Commission is on the lookout for "potentially problematic patent settlements" and has asked several pharma companies to submit copies of their patent settlement agreements made between originator and generic companies.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

GlaxoSmithKline is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products.

With counterfeit medicines increasingly appearing in legitimate supply chains and even in the clinical stages of product development, a recent white paper has outlined practical steps that may help companies address the issue of counterfeits and diverted products.

Urgent changes are required in the UK's regulation and governance of health research because medical advances are currently being stifled by unnecessary delays, bureaucracy and complexity.

Last week, the US Pharmacopeia published proposed standards for the content, language, format, and appearance of prescription drug labels in an effort to enhance patient understanding and safety.

As part of its transparency initiative, which began in June 2009, FDA launched a website during the first week of January 2011 that addresses basic questions for industry about regulated products.

Direct-to-consumer (DTC) advertising is firmly entrenched in the US, but has historically been considered as an inappropriate means of communication in Europe for prescription-only medicines.

Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.