The QMN Weekly Bulletin

To meet a deadline set by the FDA Amendments Act (FDAAA), the FDA and HHS need input from drugmakers, distributors, foreign regulators and other interested parties on how to establish a standard numerical identifier to track drugs in the supply chain.

Philips Medical Systems received a warning letter for GMP violations related to its computed tomography and nuclear imaging systems, the second GMP-related warning in two months.

A new guidance aims to help manufacturers prepare abbreviated 510(k)s for hemodialysis blood tubing sets and mitigate risks — such as malfunctions, infections and blood loss — associated with the devices.

Merck said it has received a warning letter from the Food and Drug Administration over deficiencies at one of its major vaccine manufacturing plants.

The Food and Drug Administration said Medtronic Inc. (MDT) and its two top executives signed a consent decree to halt the manufacture, sale and export of Automatic External Defibrillators.

The Pharmacy and Poisons Board is losing the war against counterfeit medicine on sale in Kenya – thanks to the lack of a law against fakes and proxy wars between manufacturers and importers.

Facing growing concern about the safety of medicines made abroad, the nation's pharmaceutical industry signaled Thursday it may be open to a new user-fee system to provide tens of millions of dollars a year for U.S. inspections of foreign drug manufacturing plants.

Hyderabad-based Dr. Reddy's Laboratories has acquired BASF's pharmaceutical contract manufacturing business and related facility at Shreveport in the U.S.

Fast growing pharmaceuticals business Specials Clinical Manufacturing has signed up for a strategic alliance with one of the most innovative companies in its field.