Business & Strategy

FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts

FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer

Registration and Listing How to register facilities and products, and how to update registrations Animal and Veterinary Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of […]

510(k) Submission Process Introduction Premarket Notification (510(k)) submissions for medical devices are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, by the Office of Product Evaluation and Quality (OPEQ).  There are 7 device types and medical specialty offices within OPEQ. The Offices of Health Technology (OHTs) are organized according to medical device […]

Search the Releasable 510(k) Database CDRH maintains searchable databases on its website containing 510(k) and PMA information A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket […]

FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs

FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

COVID-19: EU recommendations for community measures COVID-19: EU recommendations for community measures

COVID-19: EU recommendations for testing strategies Timely and accurate laboratory testing is an essential part of the management of COVID-19. Robust testing strategies have shown to be an important tool in slowing down the epidemic, supporting decisions on infection control strategies at the health care facilities and improving the knowledge of virological aspects of COVID-19.

The Best CPAP Machines Continuous positive air pressure devices or CPAP machines are often used to treat sleep apnea, a medical condition that causes a transient breath loss during the night. CPAP machines are electronic equipment that pulls air through an internal fan, moisturizes the air, pressures it, and then transmits it through the connected […]