Five-year award signals FDA’s commitment to national program utilizing electronic healthcare data to monitor the safety of FDA-regulated drugs and other medical products
Beckman Coulter, a global leader in clinical diagnostics, announced that the DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is now available for sale in the United States.
To conduct preclinical testing of locally-acting topical dermal and ophthalmic drug product formulations
The BIPRI 8-Motor Headband Is Changing the Game for Chronic Migraine Sufferers.
Intarcia Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its new drug application (NDA) for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus. Intarcia resubmitted the NDA on September 9th, 2019 and the FDA has recently communicated that it considers the NDA resubmission a complete class 2 response, setting the Prescription Drug User Fee Act (PDUFA) target action date of March 9, 2020.
Sekisui Diagnostics announces the Acucy Influenza A&B Test has received 510(k) clearance as a Class II assay from the US Food and Drug Administration (FDA), as well as, CLIA Waiver (Clinical Laboratory Improvement Amendments) for use on the Acucy Reader.
TECLens, a medical device manufacturer and SERVImed Industrial Spa, an ophthalmic medical devices manufacturer and distributor today announced their partnership aimed at development and FDA approval of a new combination product to treat keratoconus.
TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), has been named a technology partner in two coordinating centers of the FDA's Sentinel System, a national program that uses electronic health care data to monitor the safety of FDA-regulated drugs and other medical products.
ProTom International Holding Corporation ("ProTom"), a market-leading proton therapy technology manufacturer, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its Radiance 330 proton therapy system installed at Massachusetts General Hospital ("MGH") in Boston, Massachusetts.
Company Settles Legal Action Resulting in Outright Ownership of the Drug
Laser Associated Sciences' Non-Invasive Device Disrupting the Industry
DURECT Corporation (Nasdaq: DRRX) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).
Enabling on-demand monitoring of BCR-ABL levels in patients with Chronic Myeloid Leukemia (CML)
Luminex Corporation (NASDAQ: LMNX) announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES® MRSA Assay.
Experts Will Present MDX Platform at ISPOR in Denmark in Early November
Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas, on measuring the progress being made through implementing the FDA Food Safety Modernization Act
First-of-its-kind joint warning letters target 10 websites
Statement from Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health on continued efforts to evaluate materials in medical devices to address potential safety questions
Endo International plc ("Endo") (NASDAQ: ENDP) today announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances.
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology