Action Allows Perfusor® Space, Infusomat® Space, and Outlook® ES Pumps to be Used for Tracheal Delivery of Continuous Nebulized Medications into a Nebulizer
Breakthrough Therapy Designation and Submission based on positive Phase III JAVELIN Bladder 100 study results
StrataGraft Skin Tissue Could be a Potential New Treatment Option for Deep Partial-Thickness Thermal Burns, if Approved
The U.S. Food and Drug Administration took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturersExternal Link Disclaimer importing personal protective equipment and other devices.
A historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced positive feedback from its initial End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss Chemistry Manufacturing and Control (CMC) of its lead oral insulin capsule ORMD-0801.
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (MS).
Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19).
New Draft Guidance Considers Broader Evaluations Beyond Cardiovascular Outcomes Trials
In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings.
As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
We are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak.