Month: April 2013

FDA Warns of Fake Botox

Fraudulent Versions of Botox Found in the United States: FDA is alerting health care practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices. The outer carton is counterfeit, while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States. These products are being sold by unlicensed suppliers who are not part of the legitimate U.S. supply chain. FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards. These fraudulent products are considered unsafe and should not be used.

FDA budget requests $4.7 billion to ensure safety of food supply and to modernize medical

The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA’s ability to oversee imported food.

FDA Mobile Medical App Regulation Will Not Extend to Smartphones

Testifying before a US House of Representative hearing on mobile medical technology on
March 21st, FDA official Christy Foreman indicated that the agency’s approach to mobile medical app oversight will not include smartphones or tablets used to access such devices.

Buyer’s remorse over medical device tax

There appear to be a few glimmers of constructive activity in Washington, D.C. Last week, the Senate moved the ball forward on an issue that is extremely important to innovation and jobs in the United States. By passing an amendment to repeal the medical device tax by an overwhelming 79-20 votes, the Senate has done the right thing for patients and the U.S. economy.

FDA Public Workshop – Accessible Medical Device Labeling in a Standard Content and Format, April 29-30, 2013

The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling.