(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association serving more than 22,000 pharmaceutical science and manufacturing professionals, will present a conference focused on good automated manufacturing practices (GAMP).

The Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not distributed in the f

(Compliance2go: Houston) -- More organizations are striving to “go green” and develop sustainable strategies, many of which involve using computer- and cloud-based technologies.

(FDA: Silver Spring, MD) -- The FDA has announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

(FDA: Silver Spring, MD) -- The U.S.

(FDAnews: Falls Church, VA) -- Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin, which occurred in 2010 when Baxter Healthca

(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”

(FDAnews: Falls Church, VA) -- Register today for the Eighth Annual Medical Device Quality Congress, scheduled for June 8–9, 2011, in Bethesda, Maryland.

(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) has announced two new regulations that will help ensure the safety and security of foods in the United States.