The QMN Weekly Bulletin

The 8,963 domestic device manufacturers registered with the Center for Devices and Radiological Health spend more than 3 million hours annually on efforts to comply with the recordkeeping requirements of quality system regulations (QSRs), according to the FDA.

The FDA is recommending that generic manufacturers pay close attention to polymorphic forms of drug substances used in pharmaceutical processing operations, according to a new guidance issued last month.

The most essential element of an effective internal manufacturing audit program is management support and accountability, according to Susan Reilly, a consultant with Reilly & Associates.

Five people related to a lethal fake medicine that killed 13 patients last year went on trial in a Chinese court in the southern city of Guangzhou on Wednesday.

Merck has notified the CDC that the company currently reports backorders, with associated shipment delays, for both the pediatric and adult formulations of its hepatitis A vaccine, inactivated.

Devicemaker Avazzia received a warning letter after the FDA said it used unvalidated device acceptance procedures to test its transcutaneous electro-stimulators.

Law enforcers have sealed Glowmed Pharmaceuticals in Faridi Nagar and arrested its owner, Ram Kripal Gupta, for manufacturing fake drugs.

As part of the U.S. government’s effort to stockpile vaccine in case of a pandemic flu outbreak, the Department of Health and Human Services has placed an order for additional doses of GlaxoSmithKline’s avian flu vaccine.

U.S. biopharmaceutical company Gilead Sciences has pulled back from a planned €60 million investment in Dublin and has instead acquired the Cork manufacturing facilities of Nycomed for almost €34 million.