The QMN Weekly Bulletin

In noting the urgency and importance of harmonizing cGMP inspections, the FDA hopes to take a larger role in communicating with foreign inspection authorities after its acceptance into the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the FDA’s Chief Medical Officer Janet Woodcock said.

Over the last 18 months, the pendulum has swung back to aggressive FDA enforcement of current good manufacturing practices (cGMPs) for medical devices, Mark Brown, a partner with King & Spalding, said last week at the FDAnews Fourth Annual Medical Device Quality Congress.

The FDA is considering other avenues that could reduce the amount of postapproval manufacturing submissions beyond its quality by design (QbD) initiative, the agency’s Deputy Director of the Division of Therapeutic Proteins Barry Cherney said.

Albany Molecular Research Inc. has completed the $11 million purchase of two pharmaceutical manufacturing sites in India.

Daicel Chemical Industries, Ltd. and Groupe Novasep SAS, announce the formation of a strategic technical co-operation aimed at streamlining the use of chiral chromatography to manufacture late-stage clinical and commercial chiral intermediates and APIs.

Singapore's manufacturing output rose 4 percent in May from April, led by growth in pharmaceutical and offshore engineering output that compensated for lingering weakness in the electronics industry, the government said.

U.S.-based biotechnology giant Genentech started to build a $140 million microbial manufacturing facility, another shot in the arm for Singapore's biologics industry.

Southern California and Baja California, Mexico, are in danger of losing the potential to become the largest medical device manufacturing hub in the world, warns a recent report from San Diego Dialogue, a program of UC San Diego Extension.

Over the last 18 months, the pendulum has swung back to aggressive FDA enforcement of current good manufacturing practices (cGMPs) for medical devices, Mark Brown, a partner with King & Spalding, said at the FDAnews Fourth Annual Medical Device Quality Congress.