Saturday, August 24, 2019

Saturday, August 24, 2019

Latest News

New cloud-based vital signs measurement system approved by FDA

The new Vital Signs Measurement System from DynoSense Corp. was approved by the Food and Drug Administration on Aug. 13.

Some flavored e-liquid and hookah tobacco products to be removed

Warning letters were issued by the U.S. Food and Drug Administration to four companies who do not have the required marketing authorization for 44 flavors of e-liquid and hookah tobacco products.

Dynacure receives orphan drug designation for drug to treat Centronuclear Myopathies

DYN101, an investigational antisense medication for Centronuclear Myopathies (CNM), has received Orphan Drug Designation, according to the drug development company Dynacure.

Nektar Therapeutics, Bristol-Myers Squibb receive FDA breakthrough therapy designation

The U.S. Food and Drug Administration has granted breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) based on clinical data from the 2019 American Society of Clinical Oncology (ASCO) annual meeting.

EndBrainCancer Initiative urges support, offers amendments

New guidelines proposed by the Food and Drug Administration are receiving support by the EndBrainCancer Initiative (EBCI). The new guidelines focus on diversity in clinical trials.

FDA releases final PMSR requirements for combination drugs

The Food and Drug Administration (FDA) recently released guidelines for safety reporting for combination products that clarify which companies and products must abide by the final rules on post-marketing safety reporting (PMSR) requirements and how exactly to do so.

Court orders FDA to reconsider final approval of Brixadi

A December 2018 decision by the Food and Drug Administration (FDA) to block the final approval of a product from Braeburn Pharmaceuticals for the treatment of opioid use disorder has been vacated.

CoolTone Device receives FDA approval

The CoolTone device from Allergan received Food and Drug Administration approval for use in improving abdominal tone and strength. CoolTone is already approved for strengthening, toning and firming of the buttocks and thighs.

New drug application for Brinavess submitted to FDA

A New Drug Application (NDA) was resubmitted by Correvio Pharma Corporation to the Food and Drug Administration for the approval of Brinavess.

Botox approved for upper limb spasticity in children

The Food and Drug Administration approved drug company Allergan’s supplemental biologics application for Botox for patients 2-17 years old with upper limb spasticity.

VIVO System cleared by FDA

The VIVO (View Into Ventricular Onset) system from Catheter Precision has been cleared by the Food and Drug Administration for market release in the U.S.

Mortality linked to paclitaxel-coated devices remains unresolved

A two-day Food and Drug Administration advisory committee meeting found conflicting reports related to increased late mortality rates in using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs), according to the Regulatory Affairs Professionals Society (RAPS).

Study says new drug applications are almost always disclosed by drug companies

A new research study in the JAMA Internal Medicine said most new drug applications are acknowledged by drug companies.

National Center for Health Research wants clearer information disseminated on device predicates

The nonprofit National Center for Health Research (NCHR) said it believes the FDA should make patients aware that devices in the 510 (k) program have not been sufficiently tested on humans through trials, like drugs are tested before being put on the market.

FDA approves new treatment for pediatric type 2 diabetes

The Victoza injection was approved by the U.S. Food and Drug Administration earlier this month for patients 10 years and older with type 2 diabetes.

FDA says foods with toxic PFAS chemicals are ‘not a concern’

Test results from the Food and Drug Administration on food with high levels of fluorinated chemicals known as PFAS were dismissed by two high level officials of the FDA.

Guidance for premarket tobacco product applications for electronic nicotine delivery systems finalized

The guidance for manufacturers to submit new tobacco product applications through the premarket tobacco product application (PMTA) pathway was finalized on June 11. This is for electronic nicotine delivery systems (ENDS), like vapes, and the associated liquid nicotine.

Project Facilitate will help physicians access unapproved therapies

A new pilot program, Project Facilitate, was announced last week by the Food and Drug Administration to help oncology health-care professionals access unapproved therapies for their cancer patients.

Hundreds of Thousands of Deaths a Year a 'Call to Action,' FDA Says on World Food Safety Day

The first World Food Safety Day was held on June 7 with deputy commissioner for food policy and response Frank Yiannas representing the Food and Drug Administration.

R3 Stem Cell receives letter from FDA over unapproved products

R3 Stem Cell and CEO David Green received an untitled letter from the Food and Drug Administration (FDA) for unapproved stem cell products offered at its more than 50 centers around the U.S.

FDA Reporter