U.S. FDA: FDA and DEA warn website operators illegally selling opioids
First-of-its-kind joint warning letters target 10 websites
Latest News
U.S. FDA: Statement on measuring the progress being made through implementing the FDA Food Safety Modernization Act
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
GREENLEAF HEALTH: Trio Health and Greenleaf Health Partner to Apply FDA-Level Rigor to Groundbreaking Data Platform
Experts Will Present MDX Platform at ISPOR in Denmark in Early November
LUMINEX: Receives FDA 510(k) Clearance for the ARIES® MRSA Assay
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.
.jpg){kind=tracking}
Acting FDA commissioner addresses vaping illnesses before the U.S. House Energy and Commerce Subcommittee
Acting Commissioner of the U.S. Food and Drug Administration (FDA) Norman E. ("Ned") Sharpless, M.D., has presented his remarks on the FDA’s planned regulation of electronic nicotine delivery systems (ENDS), including the investigation of vaping illnesses, before the U.S. House Energy and Commerce Subcommittee.
FDA issues Salmonella, Listeria warnings for Performance Dog frozen raw pet food
A Performance Dog frozen raw pet food sample has tested positive for Salmonella and Listeria monocytogenes (L. mono), causing the U.S. Food and Drug Administration (FDA) to issue a warning to pet owners.
FDA issued 19 warning letters to companies in September
The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.
CEPHEID: Receives FDA Clearance for Xpert® BCR-ABL Ultra Test
Enabling on-demand monitoring of BCR-ABL levels in patients with Chronic Myeloid Leukemia (CML)
DURECT: Announces FDA Advisory Committee Meeting to Review POSIMIR® for the Treatment of Post-Surgical Pain
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).
Pressure mounts on politicians, FDA to react to vaping-related illnesses, deaths
According to an article on the Forbes website, vaping will impact two sectors of the financial markets the most: Big Tobacco and marijuana stocks.
FDA unveils guidances for digital health care
The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.
LASER ASSOCIATED SCIENCES: Blood Flow Monitoring Device - FlowMet-R Gets FDA 510K Clearance
Laser Associated Sciences' Non-Invasive Device Disrupting the Industry
Q BIOMED: Announces Legal Settlement and Acquisition of FDA Approved Non-Opioid Metastatic Cancer Pain Drug
Company Settles Legal Action Resulting in Outright Ownership of the Drug
PROTOM: Receives U.S. FDA 510(k) Clearance for Its Radiance 330® Single Room Proton Therapy System
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.
TRINEtX: Named Technology Partner for FDA Sentinel System
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.
TECLENS: TECLens and SERVImed Industrial Spa Announce a Partnership to Pursue U.S. FDA Approval for Trans-epithelial Corneal Cross-Linking
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.
SEKISUI DIAGNOSTICS: Announces FDA Clearance and CLIA Waiver of the Acucy™ Influenza A&B Test
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.
INTARCIA THERAPEUTICS: Provides Regulatory Update - FDA Accepts Resubmitted New Drug Application For ITCA 650
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.
FDA awards more than $4.1 million for natural history studies of rare diseases
The U.S. Food and Drug Administration (FDA) is providing more than $4.1 million in the next four years to fund two natural history studies of rare diseases.
FDA awards $15 million grant to 12 new clinical trials for rare-disease treatments
Over the next four years, the U.S. Food and Drug Administration (FDA) will be providing more than $15 million to 12 new clinical trials. The grants will help enhance the development of medical products for patients with rare diseases – mainly those affecting children.