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FDA halts monkey research denounced by Jane Goodall as ‘ shameful ’
The Food and Drug Administration has suspended experiments on the effects of nicotine in squirrel monkeys, research aimed at better understanding one of the most pernicious of addictions. Two weeks ago, famed British primatologist Jane Goodall wrote to FDA Commissioner Scott Gottlieb, urging an end to what she called “cruel and unnecessary” and “shameful” research. On […]Related:FDA targets hundreds of ‘rogue’ websites illegally selling opioids and other prescription drugsPrimal screams, blood and burns: What it’s like to survive a lightning strikeShe chose to die so sh...
Source: Washington Post: To Your Health - September 25, 2017 Category: Consumer Health News Source Type: news

FDA Conducts Major Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
September 25, 2017 -- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 25, 2017 Category: Pharmaceuticals Source Type: news

FDA rejects J & J application for new rheumatoid arthritis treatment
Janssen Biotech ’s biologics license application for an experimental arthritis therapy it's developing was rejected by the Food and Drug Administration Horsham-based Janssen Biotech, a subsidiary of Johnson& Johnson (NYSE: JNJ), was seeking approval for sirukumab as a treatment for moderately-to-severely active rheumatoid arthritis. The FDA said additional clinical data are needed to further evaluate the safety of the new drug candidate. “We are disappointed by this development as we feel… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - September 25, 2017 Category: Health Management Authors: John George Source Type: news

FDA targets hundreds of ‘ rogue ’ websites illegally selling opioids and other prescription drugs
The Food and Drug Administration targeted more than 500 websites it said were illegally selling unapproved versions of prescription medications, including opioids, antibiotics and injectable epinephrine products, the agency said Monday. The action was part of a global operation called Pangea X, led by the international police organization Interpol. That group said the international enforcement effort, […]Related:Primal screams, blood and burns: What it’s like to survive a lightning strikeShe chose to die so she could give birth. Now her newborn is dead, too.Ivanka Trump reveals struggles with postpartum d...
Source: Washington Post: To Your Health - September 25, 2017 Category: Consumer Health News Source Type: news

U.S. FDA joins Interpol crackdown on illicit online pharmacies
(Reuters) - Authorities from a record 123 countries, including the U.S. Food and Drug Administration, have taken action against hundreds of businesses suspected of illegally selling medicines over the internet, officials said on Monday. (Source: Reuters: Health)
Source: Reuters: Health - September 25, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA clears Abbott's ICD for use with MRI
Abbott Laboratories has received clearance from the U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: Abbott, CARO reach 10-year milestone Abbott to bring Xience V to China Abbott takes Xience Prime stent overseas Medtronic, Abbott bury patent-dispute hatchet Abbott begins U.S. trial of Absolute Pro stent (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 25, 2017 Category: Radiology Source Type: news

FDA announces criminal, civil actions filed against Aegerion
The Food and Drug Administration has responded to charges filed against Aegerion Pharmaceuticals, Inc., of violating the Federal Food, Drug and Cosmetic Act. (Source: Health News - UPI.com)
Source: Health News - UPI.com - September 25, 2017 Category: Consumer Health News Source Type: news

FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 25, 2017 Category: American Health Source Type: news

FDA declines to approve Intellipharma's opioid painkiller
(Reuters) - Intellipharmaceutics International Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve its long-acting opioid painkiller in its current form, backing its independent advisory panel that had raised concerns over the drug's abuse-deterrence capabilities. (Source: Reuters: Health)
Source: Reuters: Health - September 25, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Health Tip: Medication Use After a Natural Disaster
-- Natural disasters often lead to power outages and lack of refrigeration and clean water. This may render some medications less potent and potentially harmful. The U.S. Food and Drug Administration explains how this could occur: Drugs may be... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - September 25, 2017 Category: General Medicine Source Type: news

Merck ’s Keytruda receives accelerated FDA approval for GEJ adenocarcinoma
Merck ’s Keytruda (pembrolizumab) has received approval from the US Food and Drug Administration (FDA) to treat patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 24, 2017 Category: Pharmaceuticals Source Type: news

Movie ’ s Ads Protest Rules Aimed at Gay Men Donating Blood
To promote “ Jigsaw, ” Lionsgate is introducing a fan blood drive and taking aim at contentious federal regulations that add restrictions for gay men. (Source: NYT Health)
Source: NYT Health - September 24, 2017 Category: Consumer Health News Authors: BROOKS BARNES Tags: Blood Donation Advertising and Marketing Homosexuality and Bisexuality Transgender and Transsexuals American Red Cross Lions Gate Entertainment Corporation Palen, Tim Lepore, Amanda Food and Drug Administration Source Type: news

Movie ’ s Ads Protest Rules Restricting Gay Men From Donating Blood
To promote “ Jigsaw, ” Lionsgate is introducing a fan blood drive and taking aim at contentious federal regulations that add restrictions for gay men. (Source: NYT Health)
Source: NYT Health - September 24, 2017 Category: Consumer Health News Authors: BROOKS BARNES Tags: Blood Donation Advertising and Marketing Homosexuality and Bisexuality Transgender and Transsexuals American Red Cross Lions Gate Entertainment Corporation Palen, Tim Lepore, Amanda Food and Drug Administration Source Type: news

America New York Ri Wang Food Group Issues Allergy Alert on Seafood Products
America New York Ri Wang Food Group Co. ltd is recalling the following products because an allergenic ingredient, milk, was not declared in labelling. People who have an allergy or severe sensitivity to milk run the risk of serious of life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 23, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 22, 2017 Category: American Health Source Type: news

FDA declines to approve J & J arthritis drug sirukumab
(Reuters) - The U.S. Food and Drug Administration has declined to approve Johnson& Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - September 22, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Criminal and civil actions filed against Aegerion Pharmaceuticals Inc.
Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 22, 2017 Category: American Health Source Type: news

U.S. FDA declines to approve J & J arthritis drug
(Reuters) - The U.S. Food and Drug Administration has declined to approve Johnson& Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - September 22, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Many Drug Companies Fail to Conduct Timely Postapproval Safety Checks Many Drug Companies Fail to Conduct Timely Postapproval Safety Checks
In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 22, 2017 Category: Consumer Health News Tags: Internal Medicine News Source Type: news

Federal Workers Who Made a Difference
The federal government gets a bad rap: it is constantly described as bloated and clunky, its workers as inefficient and ineffectual. Yet by and large, the men and women who make up the federal workforce rise above the criticism, put one foot in front of the other and do their job. Rarely is the work they do acknowledged, much less praised. But for the past 16 years, the Samuel J. Heyman Service to America Medals, or Sammies, have sought to change that by honoring federal employees who have an outsize impact on the country and the world. Below, the 2017 Sammie winners, chosen by the nonpartisan Partnership for Public Servic...
Source: TIME.com: Top Science and Health Stories - September 22, 2017 Category: Consumer Health News Authors: Maya Rhodan Tags: Uncategorized Government Source Type: news

Identification and characteristics of time-related shifts in suicide-related event frequency during smoking cessation treatment with varenicline - Akimoto H, Wakiyama H, Oshima S, Negishi A, Ohara K, Numajiri S, Okita M, Ohshima S, Inoue N, Kobayashi D.
OBJECTIVES: To survey time-related shifts in number of suicide-related events (SRE) during smoking cessation treatment with varenicline (VAR) in cases from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), as well as the c... (Source: SafetyLit)
Source: SafetyLit - September 22, 2017 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

A Chinese Robot Has Performed the World ’s First Automated Dental Implant
Robots could soon be operating on you by themselves at the dentist clinic. In China, a robot dentist installed two dental implants for a woman last Saturday, in what could be the world’s first fully automated dental implant surgery, reports the South China Morning Post. Human doctors supervised the whole procedure but did not actively intervene. The surgery, which took place in the city of Xi’an, was first reported by the state-run Science and Technology Daily. According to the report, the robot followed a set of pre-programmed commands to install the dental implants. Experts said that the implants were fitted ...
Source: TIME.com: Top Science and Health Stories - September 22, 2017 Category: Consumer Health News Authors: Kevin Lui Tags: Uncategorized China onetime Source Type: news

FDA clarifies if microneedling should be classified as a medical device
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post FDA clarifies if microneedling should be classified as a medical device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Emergency contraception not as accessible as it should be, says CU Anschutz study
(University of Colorado Anschutz Medical Campus) Efforts to remove barriers to accessing emergency contraception (EC) scored victories in 2013, when the US Food and Drug Administration removed age restrictions on over-the-counter sales of the levonogestrel drug Plan B. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 22, 2017 Category: International Medicine & Public Health Source Type: news

Janssen Receives Complete Response Letter From U.S. FDA for Sirukumab Biologics License Application
HORSHAM, PA, September 22, 2017 – Janssen Biotech, Inc. (Janssen) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
KENILWORTH, N.J.--(BUSINESS WIRE) September 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company ’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 22, 2017 Category: Drugs & Pharmacology Source Type: news

The association between leukotriene-modifying agents and suicidality: a review of literature - Khalid F, Aftab A, Khatri S.
BACKGROUND: In 2008 Food and Drug Administration issued a warning regarding a possible association between leukotriene-modifying agents and suicidality. OBJECTIVE: The warning remains controversial and this review of literature is an attempt to exa... (Source: SafetyLit)
Source: SafetyLit - September 22, 2017 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

BioCryst scores FDA approval on flu treatment for children
On the heels of an $80 million public offering, Research Triangle Park-based BioCryst Pharmaceuticals (Nasdaq: BCRX) has landed U.S. Food and Drug Administration approval for its injectable flu treatment in pediatric patients. BioCryst submitted its supplemental new drug application for RAPIVAB (peramivir injection) earlier this year, with the FDA ultimately granting a priority review. In 2014, the FDA approved RAPIVAB for treating adults with the flu and the firm has also been approved in a number… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 21, 2017 Category: Biotechnology Authors: Jennifer Henderson Source Type: news

FDA warns of death, liver injury risks from Intercept's drug
(Reuters) - The U.S. Food and Drug Administration (FDA) warned on Thursday that Intercept Pharmaceuticals Inc's drug Ocaliva was being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death. (Source: Reuters: Health)
Source: Reuters: Health - September 21, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA clears 2 Brainlab software applications
The U.S. Food and Drug Administration (FDA) has cleared two software applications...Read more on AuntMinnie.comRelated Reading: Brainlab ships planning software package Brainlab to show updated radiosurgery software at AAPM 2016 Brainlab touts progress with patient registry Brainlab to license radiosurgery software Brainlab touts preliminary ExacTrac study results (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 21, 2017 Category: Radiology Source Type: news

Many drug companies fail to conduct timely safety checks on medicines after FDA approval
(Reuters Health) - In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market. (Source: Reuters: Health)
Source: Reuters: Health - September 21, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

First duodenoscope with disposable distal cap approved by FDA
The U.S. Food and Drug Administration has cleared the first duodenoscope with a disposable distal cap for use in the upper gastrointestinal tract. (Source: Health News - UPI.com)
Source: Health News - UPI.com - September 21, 2017 Category: Consumer Health News Source Type: news

FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease
The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Releases Cefaly(R) for Acute Treatment of Migraine Attacks
NEW YORK, Sept. 21, 2017 -- (Healthcare Sales & Marketing Network) -- CEFALY Technology announces today that on Friday, September 15th, the U.S. Food and Drug Administration (FDA) released the use of a new Cefaly® medical device for the acute treatmen... Devices, Neurology, FDA CEFALY Technology, trigeminal nerve stimulation, e-TNS, migraine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 21, 2017 Category: Pharmaceuticals Source Type: news

A rapid alternative to standard safety tests for lentiviral vectors
(Cell Press) A new, publicly available test to assess the safety of cell therapy products altered by lentivirus generates results within a few hours, potentially hastening the pace at which viral immunotherapies move into clinical trial. Current assays required by the US Food and Drug Administration take about six weeks to complete. The rapid test, which does not have a significant risk of false positives, is also a fraction of the cost of the standard approach. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - September 21, 2017 Category: Cancer & Oncology Source Type: news

First Source Issues Allergy Alert On Undeclared Milk In Tasty Treats Nonpareils Milk Chocolate
First Source of Pico Rivera, CA, is recalling Tasty Treats Nonpareils Milk Chocolate because it contains undeclared milk. People who have an allergy or severe sensitivity to Milk run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 21, 2017 Category: Food Science Source Type: news

FDA Issues Warning About Mixing Opioid Addiction Treatments With Other Meds
TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity. The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution. The agency said a growing number of people fighting opioid addiction with methadone or buprenorphine also take other prescription drugs that slow action of the central nervous system. The warning lists several dozen brand-name and generic drugs that could be risky, in...
Source: JEMS Patient Care - September 20, 2017 Category: Emergency Medicine Authors: Linda A. Johnson, Associated Press Tags: Patient Care News Source Type: news

FDA Issues Warning About Mixing Opioid Addiction Treatments With Other Meds
TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity. The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution. The agency said a growing number of people fighting opioid addiction with methadone or buprenorphine also take other prescription drugs that slow action of the central nervous system. The warning lists several dozen brand-name and generic drugs that could be risky, in...
Source: JEMS: Journal of Emergency Medical Services News - September 20, 2017 Category: Emergency Medicine Authors: Linda A. Johnson, Associated Press Tags: Patient Care News Source Type: news

Nature Supplement Inc. Issues Voluntary Florida Recall of Vegetable Vigra Due to Undeclared Sildenafil
Natures Supplement, Inc. is voluntarily recalling 260 bottles of VEGETABLE VIGRA, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy has not been established, therefore subject to recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: Food Science Source Type: news

Bucks County specialty pharmaceutical company files plans for $100M IPO
The company received a Food and Drug Administration product approval earlier this week. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - September 20, 2017 Category: Health Management Authors: John George Source Type: news

Bucks County specialty pharmaceutical company files plans for $100M IPO
The company received a Food and Drug Administration product approval earlier this week. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 20, 2017 Category: Biotechnology Authors: John George Source Type: news

Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales
Death Wish Co ffee Co. (“Death Wish”), the Round Lake, N.Y.-based coffee producer known for producing the ‘World’s Strongest Coffee’, has initiated a recall its 11-oz Death Wish Nitro Cold Brew cans. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: Food Science Source Type: news

Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients.
Newark, CA, Gadget Island, Inc. is voluntarily recalling to the consumer level. The products have been found to contain undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction
Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder reg ain control over their lives. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. Addressing the epidemic of opioid addiction is my highest public health priority. One element of t...
Source: Food and Drug Administration - September 20, 2017 Category: American Health Source Type: news

FDA clears first duodenoscope with disposable distal cap
The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: American Health Source Type: news

FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
[8-31-2016] A U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 20, 2017 Category: Drugs & Pharmacology Source Type: news

The FDA Encourages New Treatments for Sickle Cell Disease
The U.S. Food and Drug Administration is collaborating with patients, academics, and the pharmaceutical industry to encourage the development of new treatments for sickle cell disease (SCD). (Source: FDA Consumer Health Information Updates)
Source: FDA Consumer Health Information Updates - September 20, 2017 Category: Consumer Health News Source Type: news

FDA Approves ROVI Contract Manufacturing Injectables plant in Madrid
Laboratorios Farmac é uticos Rovi (ROVI) has announced that the US Food and Drug Administration (FDA) has approved its contract manufacturing injectables plant in Madrid for filling syringes that are prefilled with water for injection using the termina … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 20, 2017 Category: Pharmaceuticals Source Type: news

China has a new medical device classification catalog: what you need to know
Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018. Read the whole story on our sister site, Medical Design & Outsourcing The post China has a new medical device classification catalog: what you need to know appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: MassDevice Tags: Regulatory/Compliance China Food & Drug Administration (CFDA) Source Type: news

Mesothelioma Clinical Trials Involve Gene Therapy
Treatment options for malignant mesothelioma may soon include customized gene therapy, according to thoracic surgeon and scientist Dr. Prasad Adusumilli at Memorial Sloan Kettering Cancer Center in New York. Gene therapy involves a laboratory reprogramming of a patient’s own T cells, which are a type of white blood cell, to recognize and destroy the cancer. The U.S. Food and Drug Administration (FDA) recently approved the first gene therapy specifically for pediatric leukemia, signaling the start of a new approach to cancer treatment in this country. The newly approved treatment is also known as chimeric antigen rece...
Source: Asbestos and Mesothelioma News - September 19, 2017 Category: Environmental Health Authors: Matt Mauney Tags: CAR T cell therapy checkpoint blockade chimeric antigen receptor T cell therapy Dr. Andy Haas Dr. Prasad Adusumilli Dr. Scott Gottlieb FDA Commissioner gene therapy cancer gene therapy for mesothelioma immunotherapy clinical trial mali Source Type: news