The Food and Drug Administration Safety and Innovation Act (S. 3187) was signed into law by President Obama on July 9th of this year. The Act brings numerous changes for the drug and medical device industry but all of the attention so far has been on the Prescription...
The FDAImports.com team is pleased to welcome Steven A. Johnson to our team! Mr. Johnson joins the firm as Principal, bringing nearly 20 years of FDA, Pharmaceutical, Biotech and Medical Device experience to the firm. He will be assisting clients with biotech and...
If you remember only one thing about FDA-related legal matters involving imported products it should be this: Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse...
In February 2012, news of fake Avastin in the United States hit the news wires. Cancer patients were being administered water while under the impression that it was the actual cancer treatment drug, Avastin. People were outraged. Weeks later, another shipment of...
Companies that are directly affected by a major natural disaster or weather event, such as the Joplin, Missouri tornadoes or the earthquake and tsunami in Japan, should expect a heightened level of federal and state oversight in the future especially when it comes to...
Pharmaceutical companies in the U.S. might have thought that because the recently enacted Food Safety Modernization Act (FSMA) enhances food authorities at FDA, that Pharmaceutical manufacturers or importers have escaped unscathed. But this is an unsafe and incorrect...
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