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ICYMI: Why 2017 medicine approvals matter
This week, the U.S. Food and Drug Administration ’s (FDA) Center for Drug Evaluation and Research (CDER)released its 2017 New Drug Therapy Approvals report. Last year marked an extraordinary milestone for the biopharmaceutical industry and the FDA with major medicine approvals. According to the report, the FDAapproved 46 new molecular entities for a range of disease states -- the highest number of new medications in 21 years.
Source: The Catalyst - January 12, 2018 Category: Pharmaceuticals Tags: FDA Drug Development Multiple Sclerosis PDUFA New Era of Medicine Source Type: news

Nation's first cardiac ablation with mapping system recently cleared by the FDA performed at Penn Medicine
(University of Pennsylvania School of Medicine) After eight years of failed treatment for persistent atrial fibrillation (AF), Janet Szilagyi, 78 of Clayton, New Jersey, became the first patient in the United States to undergo cardiac ablation -- a procedure in which an electrophysiologist will scar or destroy tissue in the heart that's allowing incorrect electrical signals to cause an abnormal heart rhythm -- using an intraoperative imaging and mapping system recently cleared by the Food and Drug Administration (FDA).
Source: EurekAlert! - Medicine and Health - May 3, 2018 Category: International Medicine & Public Health Source Type: news

Regulation of Regenerative Medicine Products.
Authors: Gee AP Abstract Cellular therapies have moved to the forefront based upon promising results from clinical trials using both chimeric antigen receptor T lymphocytes to treat leukemia and other cell types to restore structure and function to tissues that have been damaged by disease or physical injury. The pace at which these treatments have evolved has posed a regulatory challenge to agencies, such as the Food and Drug Administration (FDA). This chapter describes how a specific regulatory strategy was developed and how it has evolved in response to the demand for these new therapies. PMID: 30238372 [PubMed - in process]
Source: Advances in Experimental Medicine and Biology - September 23, 2018 Category: Research Tags: Adv Exp Med Biol Source Type: research

Putting 2018 medicine approvals in context
Last year, the U.S. Food and Drug Administration ’s (FDA) Center for Drug Evaluation and Research (CDER)approved a record number of novel new medicines with 59 new molecular entities (NMEs). While medicine approval numbers vary each year, 2018 was a particularly exciting year for drug development. These novel approvals demonstrate biopharmaceutical research companies ’ continued commitment to developing innovative medicines and highlight the FDA and Commissioner Gottlieb’s commitment to strengthening the Agency’s human drug review program through ongoing implementation of the Prescription Drug User Fee Act (PDUFA)....
Source: The Catalyst - January 23, 2019 Category: Pharmaceuticals Tags: New Era of Medicine FDA Rare Diseases PDUFA Research and Investment Source Type: news

Controversy swirls around adipose-derived cell therapies for reparative medicine
(Mary Ann Liebert, Inc./Genetic Engineering News) Challenging the US Food and Drug Administration's current approach to evaluating and approving adipose-based cell therapies used in reparative medicine, a group of researchers proposes a new path forward that focuses on patient safety and includes evidence-based medical practice.
Source: EurekAlert! - Medicine and Health - February 19, 2020 Category: International Medicine & Public Health Source Type: news

Letter of Authorization: SARS-CoV-2 RT-PCR Test; Infectious Disease Diagnostics Laboratory, Department of Pathology and Laboratory Medicine at the Children ’s Hospital of Philadelphia
Source: U.S. Food and Drug Administration (FDA). Published: 4/2/2020. This one-page letter authorizes the emergency use of the Infectious Disease Diagnostics Laboratory, Department of Pathology and Laboratory Medicine at the Children ’s Hospital of Philadelphia SARS-CoV-2 PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test). (PDF)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - April 2, 2020 Category: International Medicine & Public Health Source Type: news

Keck Medicine of USC launches clinical trial to study anti-inflammatory drug as treatment for COVID-19
(University of Southern California - Health Sciences) Keck Medicine of USC physicians are launching a clinical trial to evaluate the efficacy and safety of baricitinib, an anti-inflammatory drug approved by the Food and Drug Administration to treat rheumatoid arthritis, as a possible treatment for patients with moderate to severe COVID-19.
Source: EurekAlert! - Medicine and Health - May 6, 2020 Category: International Medicine & Public Health Source Type: news

Nigeria: NAFDAC Warns Against Use of Unverified Covid-19 Herbal Medicine
[This Day] The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerian researchers in the nation's ivory towers and other herbal medicine practitioners to desist from parading unverified medicinal products as suitable for curing COVID -19, without NAFDAC's approval.
Source: AllAfrica News: Health and Medicine - July 19, 2021 Category: African Health Source Type: news

Understanding and interpreting artificial intelligence, machine learning and deep learning in Emergency Medicine
Introduction The field of artificial intelligence (AI) has been developing more prominently for over half a century. Innovations in computer processing power and analytical capabilities coupled with the availability of huge amounts of routinely collected data has meant that AI research and technology development has grown exponentially in recent years. The results of this growth can be seen in emergency medicine (EM)—with the Food and Drug Administration approving the first AI software as a medical device for wrist fracture detection in 2018. As of 2021, several more have been approved—for triage, X-ray identif...
Source: Emergency Medicine Journal - April 21, 2022 Category: Emergency Medicine Authors: Ramlakhan, S., Saatchi, R., Sabir, L., Singh, Y., Hughes, R., Shobayo, O., Ventour, D. Tags: Editor's choice Practice review Source Type: research

As Flu Rages, U.S. Releases Medicine from National Stockpile
WASHINGTON — The Biden administration said Wednesday it will release doses of prescription flu medicine from the Strategic National Stockpile to states as flu-sickened patients continue to flock to hospitals and doctors’ offices around the country. This year’s flu season has hit hard and early. Some people are even noticing bare shelves at pharmacies and grocery stores when they make a run for over-the-counter medicines as cases have spiked. The Centers for Disease Control and Prevention estimates that the flu has resulted in 150,000 hospitalizations and 9,300 deaths so far this season. “Jurisdictio...
Source: TIME: Health - December 21, 2022 Category: Consumer Health News Authors: AMANDA SEITZ/AP Tags: Uncategorized healthscienceclimate medicine wire Source Type: news

Dietary supplements and athletes: 5 things to know now
At the 2014 Sochi Olympics, a German biathlete and an Italian bobsledder tested positive for substances banned by the World-Anti-Doping Agency (WADA) — methylhexanamine and dimethhylamphetamine. Both athletes had ingested these substances as part of a dietary supplement they had been led to believe was free of contaminants. However, some banned substances are susceptible to inadvertent use because the manufacturers list them under less recognizable names on the product label. Both athletes were stripped of their medals. In other cases, athletes’ use of banned substances is more intentional. Scores of Russian athletes h...
Source: Thrive, Children's Hospital Boston - August 11, 2016 Category: Pediatrics Authors: Laura Moretti Tags: Health & Wellness Teen Health dietary supplements performance-enhancing drugs Source Type: news

Tobacco Advertising and Promotional Expenditures in Sports and Sporting Events - United States, 1992-2013.
Abstract Smokeless tobacco has been actively promoted by tobacco companies using endorsements by major sport figures, and research indicates that tobacco advertising can lead to youth initiation of tobacco use (1,2). Television and radio advertisements for cigarettes and smokeless tobacco have been prohibited since 1969,* and the 1998 Master Settlement Agreement(†) further prohibited tobacco companies from targeting youths with tobacco product advertisements in specified areas. In 2010, the Food and Drug Administration (FDA), under authority of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA),...
Source: MMWR Morb Mortal Wkl... - August 20, 2016 Category: Epidemiology Authors: Agaku IT, Odani S, Sturgis S, Harless C, Glover-Kudon R Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Children ’ s Robitussin And Dimetapp Cough Medicines Recalled For Potential Overdose Risks
(CNN) — Parents take note: GlaxoSmithKline Consumer Healthcare has voluntarily recalled three lots of its children’s cough syrups — Children’s Robitussin Honey Cough and Chest Congestion DM and Children’s Dimetapp Cold and Cough — due to the products having incorrect dosing cups in their packaging. That means parents might accidentally overdose a child by putting too much syrup in the cup. Symptoms of overdose of either product may include impaired coordination, elevated blood pressure, dizziness, seizure, nausea, vomiting, constipation, diarrhea, abdominal pain, hallucinations, among other conc...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - June 19, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Consumer Health News CNN Cough Syrup Recall Source Type: news

DePuy Synthes Receives 510(k) FDA Clearance for VELYS ™ Robotic-Assisted Solution Designed for Use with the ATTUNE® Total Knee System
PALM BEACH GARDENS, FL., January 19, 2021 – Today, The Johnson & Johnson Medical Devices Companies* announced that DePuy Synthes** has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VELYS™ Robotic-Assisted Solution designed for use with the ATTUNE® Total Knee System and its cleared indications for use. It will become part of the broader VELYS Digital Surgery Platform of connected technologies. With a growing and aging patient population, demand for joint replacement surgery is increasing. But across the industry, data shows up to 20% of knee replacement patients aren’t satisfi...
Source: Johnson and Johnson - January 19, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news