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...
What happened when observers pointed out that the Congressional Budget Office estimated it would cost $1.4 billion over 5 years to implement FSMA even though Congress only gave FDA a $50 million boost for this year? Silence. What happened when industry and consumers...
FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a...
The FDA has “a total of about 50 full time equivalents to regulate a very large and growing industry,” said Michael Landa, Director of the Center for Food Safety and Applied Nutrition at the FDA in a statement made during a Senate hearing on the safety of cosmetics a...
Beijing has announced plans to ban people convicted of food safety crimes from investing in and operating related businesses for the rest of their lives. According to the new draft amendment to Beijing Food Safety regulations, companies whose lack of food safety...
As the FDA launches its pilot program related to tracking high-risk foods, we are once again reminded of the ongoing difficulties FDA experiences when it comes to choosing between acting quickly and acting thoughtfully. Think back to 2011’s food safety crises...
FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap...
FDAImports.com recently helped a Chinese company obtain the first Green Ticket from FDA Import Alert #99-29, a sweeping and unshakeable Import Alert for Chinese protein products due to the presence of Melamine and/or Melamine Analogs. This Import Alert traces back to...
FDAImports.com Founder and CEO, Benjamin England, was featured in this month’s FDLI Update for his presentation during Food Week 2012 entitled, “How to Use Existing Quality Systems to Comply with FSMA Requirements.” Mr. England co-presented at the Food and Drug Law...
Below are some of our favorite quotes and exchanges from last week’s Energy and Commerce Subcommittee on Health hearing, “Examining the Current State of Cosmetics.” If you haven’t read our first blog about it please read that here. What follows below are some of the...
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