?The US Food and Drug Administration (FDA) conducts tens of thousands of inspections of pharmaceutical, medical device and biological manufacturing facilities each year, resulting in thousands of subsequent reports noting deficiencies.
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
JAMA Study Shows Deep Public Mistrust in FDA, Belief Agency is Suppressing Cures; A new study published in the Journal of the American Medical Association’s (JAMA) Internal Medicine portrays worrying information about public trust in the US Food and Drug Administration (FDA).
US medical device market regulators are putting the burgeoning practice of 3-D printing for medical devices under the microscope, having announced a public workshop on the issue in October 2014 at the Food and Drug Administration’s headquarters.
The US Food and Drug Administration has stopped notarizing Center for Devices and Radiological Health (CDRH) export certificates including Certificates to Foreign Government (CFG), Certificates of Exportability and Non Clinical Research Use Only Certificates.
US medical device market regulators have updated guidance first issued in 2012 on the FDA’s Pre-Submission feedback program for medical device manufacturers undergoing Investigational Device Exemptions (IDE), Premarket Approval (PMA), 510(k) premarket notification or other premarket reviews.
The Chinese government’s State Council Executive Committee has approved updates to the country’s medical device regulatory system, bringing the long-awaited revisions closer to actual implementation.
The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.
U.S. device makers laud India’s new Medtech proposal; New laws proposed by India healthcare regulators would for the first time treat medical devices as a category distinct from pharmaceuticals.
In Major Victory for Industry, FDA says Existing 510(k) Guidance to Remain ‘Mostly Unchanged’; The US Food and Drug Administration (FDA) has released the text of a congressionally mandated report outlining its plans for the future of its medical device premarket notification process, also known as the 510(k) clearance process, saying that it intends to largely leave its existing 1997 guidance document as-is.