The QMN Weekly Bulletin

As part of the FDA’s Quality by Design (QbD) initiative, the agency’s Chief Medical Officer Janet Woodcock is urging the industry to take risks associated with submitting QbD new drug applications in order to obtain regulatory flexibility in postapproval manufacturing submissions.

As the FDA moves forward with its risk-based approach for determining inspection priorities, device manufacturers that produce more frequently recalled products should expect more facility inspections, FDA Senior Recall Coordinator Michael Verdi said.

The FDA will soon issue guidelines specific to combination products, resulting in increased regulatory action against cGMP violations, which will affect both laboratories and manufacturing divisions, a white paper by a former FDA official predicts.

Indian pharmaceutical companies have joined hands to fight allegations in the US about the poor quality of drugs from the country.

Shelhigh of Union Township yesterday agreed not to distribute implantable medical devices used in heart surgery and other procedures until its manufacturing methods, facilities and controls are found to be in compliance with Food and Drug Administration standards.

Aegis Analytical Corporation, a leading provider of manufacturing performance management software and services utilized by major life sciences companies, announced that Bristol-Myers Squibb Company selected Aegis’ Discoverant software to achieve greater process understanding and control during process development for new products.

Specialists from a variety of disciplines should evaluate product complaints as part of a solid postmarketing surveillance system, Gaurang Patel, associate medical director for product safety with Cordis, said at a recent industry conference.

The federal government awarded $132.5 million in contracts to MedImmune and Sanofi Pasteur in order to ramp up their capacity to produce flu vaccines.

Pune-based pharma packaging company Bilcare is talking to pharma regulators to introduce an electronic device that will allow pharma companies to keep track of their drugs, wherever they are at a given point of time.

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