Thursday, February 20, 2020

Thursday, February 20, 2020

Latest News

Taxpayers Protection Alliance recommends FDA reforms

The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply.

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.

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.

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.

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.

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)

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.

Vaping illnesses caused by illegal substances, AVA says

As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.

CARDIOVASCULAR SYSTEMS, INC.: Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip

U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease

WEST CANCER CENTER: The first center in the country to offer the first FDA-approved Mesothelioma treatment in more than 15 years

A clinical study showed that the NovoTTF-100L™ System in combination with chemotherapy may help people with malignant pleural mesothelioma extend their lives

EXACT SCIENCES: Cologuard® Gains FDA Approval For Use In Younger Americans, Ages 45 To 49

Stool DNA test offers a sensitive, noninvasive, at-home option to screen for colorectal cancer, second deadliest cancer in U.S.

FDA draft guidance elicits mixed reactions

Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from stakeholders.

EMMAUS LIFE SCIENCES: Reinforces Positive Outcomes of Endari ® Clinical Trials, Including Efficacy Findings That Led to FDA Approval

Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in sickle cell disease (SCD) treatment, today released the following summary review of the clinical trials and efficacy findings for Endari®.

INSULET CORPORATION: Insulet’s Omnipod DASH™ System Now FDA Cleared as an Alternate Controller Enabled (ACE) Infusion Pump

Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for an Alternate Controller Enabled Infusion Pump (ACE Pump).

FDA removes alcohol contraindication from Addyi

The U.S. Food and Drug Administration (FDA) removed the alcohol contraindication from Addyi, the only FDA-approved treatment for pre-menopausal women for Hypoactive Sexual Desire Disorder (HSDD).

Research and Markets holds seminar on medical device obstacles held a seminar in San Diego on Sept. 12 and 13 entitled, "Managing Your Complaints and Obstacles in Post-Market Requirements – Results from Top Medical Device Observations During an Inspection.”

FDA Reporter