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February 1, 2016
Most foreign shippers are aware that specific documentation requirements such as commercial invoice and the use of appropriate Harmonized Tariff Schedule (HTS) codes are required for a commercial shipment to enter the United States from abroad. When an import shipment is regulated by the Food and Drug Administration (FDA), additional data elements can make the
December 28, 2015
Have you ever heard of PREDICT for FDA import clearance? When a shipment regulated by the Food and Drug Administration (FDA) arrives at the US border, there are two options: It can either be released immediately by the federal agency without further examination, or it can experience a delay at the American port of entry.
November 10, 2015
Healthcare supply chains are becoming increasingly global and complex. Biopharma products are often manufactured in one part of the world and sold in another, while clinical trials are conducted in remote populations with limited access to medicine. As a result, healthcare shipments have to cross borders and even continents for package contents to reach final
January 8, 2014
This year the Food and Drug Administration (FDA) issued a report titled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” (cGMP stands for Current Good Manufacturing Practices). The Medicines and Healthcare products Regulatory Agency (MHRA), the equivalent of the FDA in the United Kingdom, has long adopted a risk-based inspection strategy. A risk corresponds to the possibility that a function, a procedure or a product does not perform as expected. Risk management programs consist of activities and actions to control risks.
August 6, 2013
Healthcare shippers, including pharmaceutical, biotechnological, medical device, equipment and diagnostics companies carefully select their transportation providers. Obviously, pricing, reputation, reliability, expertise and infrastructure have always played an important role in selection decisions.
March 14, 2012
We have all heard of generic drugs and realize that they are much cheaper than the original brand name products. As a matter of fact, many pharmaceutical blockbusters already face or are about to face competition with the release of alternative generic products in the next few years. Articles mentioning this “patent cliff” appear regularly in magazines and newspapers.