Re: Response to acute monotherapy for major depressive disorder in randomized, placebo controlled trials submitted to the US Food and Drug Administration: individual participant data analysis
(Source: BMJ Comments)
Source: BMJ Comments - August 17, 2022 Category: General Medicine Source Type: forums

Neuromodulation Offers Hope for Patients with Long-COVID
Neuromodulation offers hope for patients with long-COVID With increasing focus being placed on the long-term impact COVID-19 can have, and the demand for effective treatments also growing concurrently, Marom Bikson (New York City, USA) outlines the potential neuromodulation holds regarding this unmet need. There is an urgent need to best understand... neuronewsinternational.com "Because COVID-19 is ubiquitous and will become endemic, PASC is especially troublesome in regard to cumulative disease burden. While vaccines and drugs are US Food and...
Source: Student Doctor Network - June 24, 2022 Category: Universities & Medical Training Authors: drusso Tags: Pain Medicine Source Type: forums

Paige Receives First Ever FDA Approval for AI Product in Digital Pathology
Paige, the global leader in AI-based diagnostic software in pathology, today announced that the U.S. Food and Drug Administration (FDA) has granted de www.businesswire.com (Source: Student Doctor Network)
Source: Student Doctor Network - September 23, 2021 Category: Universities & Medical Training Authors: KeratinPearls Tags: Pathology Source Type: forums

Generic Viagra
Well generic Viagra has been approved. Teva has 180 days of exclusivity. The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA. Today, the U.S. Food and Drug Administration approved the first generic version of Viagra (sildenafil citrate), for the treatment of erectile dysfunction. Teva Pharmaceutical Industries received approval to market generic sildenafil citrate tablets in 25 mg, 50 mg, and 100 mg... Generic Viagra (Source: Student Doctor Network)
Source: Student Doctor Network - July 23, 2020 Category: Universities & Medical Training Authors: farmadiazepine Tags: Pharmacy Source Type: forums

Pharmacist will be able to order and administer Covid-19 test.
HHS Statements on Authorizing Licensed Pharmacists to Order and Administer COVID-19 Tests Earlier today, the Office of the Assistant Secretary for Health issued new guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to order and administer COVID-19 tests that the Food and Drug Administration has authorized. www.hhs.gov "the Office of the Assistant Secretary for Health issued new guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to order and admin...
Source: Student Doctor Network - April 9, 2020 Category: Universities & Medical Training Authors: HandsomeVampire Tags: Pharmacy Source Type: forums

At $2 Million, New Novartis Drug Is Priciest Ever
Novartis said it plans to price its recently approved gene therapy at $2.125 million, making it the world’s most expensive medicine. www.wsj.com Novartis slaps $2M-plus pricetag on newly approved gene therapy Zolgensma—and cost watchdogs approve Industry watchers have been speculating for months about just how high Novartis would price gene therapy Zolgensma—and just how payers would cover the "transformative" spinal muscular atrophy treatment. Now t...
Source: Student Doctor Network - June 18, 2019 Category: Universities & Medical Training Authors: Lawper Tags: Topics in Healthcare Source Type: forums

Not that surprising- SIS alert
SIS Patient Safety Alert 8/31/2016: Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death This is an important alert from the Spine Intervention Society. We send out Patient Safety Alerts when we receive important information regarding products or services that can impact your patients' safety. ISSUE: A review by the U.S. Food and Drug Administration (FDA) has found that the... Not that surprising- SIS alert (Source: Student Doctor Network)
Source: Student Doctor Network - September 1, 2016 Category: Universities & Medical Training Authors: Extralong Source Type: forums

Re: Why aren’t the US Centers for Disease Control and Food and Drug Administration speaking with one voice on flu?
(Source: BMJ Comments)
Source: BMJ Comments - February 10, 2015 Category: Journals (General) Source Type: forums

New remote maternal monitoring system - Sense4Baby,Europe
New system has launching for maternity purpose.Recently Mobile interoperability leader AirStrip and Telenatal launched "Sense4Baby" wireless fetal monitoring system.It is launched in 13 European countries.It is used to perform remote maternal and fetal monitoring including for high-risk pregnancies.It already received clearance from the US Food and Drug Administration by medical professionals. Source: (Source: Cystic Fibrosis Pregnancy Forum)
Source: Cystic Fibrosis Pregnancy Forum - February 6, 2015 Category: Respiratory Medicine Authors: emilymainzer Tags: Pregnancy Source Type: forums

Mevion Higher speed pencil beam scanning - Hyperscan proton therapy system
One of the radiation therapy company from US named Mevion Medical systems introduced a Hyperscan system which is going to deliver high speed pencil beam scanning.Current pencil beam systems are very sensitive to motion.This latest Hypersacn system delivers less sensitive to patient and tumour motions.As of now it is not approved by US FDA (Food and Drug Administration). Details: (Source: Cystic Fibrosis CFTR Modulation and Gene Therapy Forum)
Source: Cystic Fibrosis CFTR Modulation and Gene Therapy Forum - September 18, 2014 Category: Respiratory Medicine Authors: emilymainzer Tags: CFTR Modulation and Gene Therapy Talk Source Type: forums

New treatment for metastatic cervical cancer for women
It is good to hear that new treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone. Recently US Food and Drug Administration has accepted sBLA (supplemental Biologics License Application).To know more details on this : http://regulatoryaffairs.pharmaceuti...160714-4318707 (Source: Cystic Fibrosis CFTR Modulation and Gene Therapy Forum)
Source: Cystic Fibrosis CFTR Modulation and Gene Therapy Forum - July 17, 2014 Category: Respiratory Medicine Authors: emilymainzer Tags: CFTR Modulation and Gene Therapy Talk Source Type: forums

FDA Investigation Finds No Excess Bleeding Risk for Dabigatran
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the full FDA statement. Here is the first paragraph of the statement: The U.S. Food and Drug Administration (FDA) has evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Co...
Source: CardiologyNetwork.com - October 13, 2013 Category: Cardiology Authors: Indian Diabetics Foundation Team Source Type: forums