FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder (OUD). The reSET-O app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a health care professional, (Source: World Pharma News)
Source: World Pharma News - December 10, 2018 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

FDA approves eye surgery KC-area doctor helped develop
The Food and Drug Administration has approved  an advancement in eye surgery developed and tested by five doctors nationwide, one of whom is Kansas City-based Dr. John Doane.  Small Incision Lenticule Extraction (SMILE) is a minimally invasive procedure first approved in 2016 for patients with nearsightedness.   The FDA approved the s urgery for people with astigmatism in October, expanding the procedure’s scope to more than 90 percent of the population seeking vision correction, Doane… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 10, 2018 Category: Pharmaceuticals Authors: Lily Lieberman Source Type: news

FDA approves eye surgery KC-area doctor helped develop
The Food and Drug Administration has approved  an advancement in eye surgery developed and tested by five doctors nationwide, one of whom is Kansas City-based Dr. John Doane.  Small Incision Lenticule Extraction (SMILE) is a minimally invasive procedure first approved in 2016 for patients with nearsightedness.   The FDA approved the s urgery for people with astigmatism in October, expanding the procedure’s scope to more than 90 percent of the population seeking vision correction, Doane… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 10, 2018 Category: Biotechnology Authors: Lily Lieberman Source Type: news

The J.M. Smucker Company Issues Voluntary Recall of Specific Lots of 9Lives ® Protein Plus® Wet, Canned Cat Food Due to Low Levels of Thiamine (Vitamin B1)
The J.M. Smucker Company today announced a voluntary recall of specific lots of 9Lives ® Protein Plus® wet, canned cat food due to possible low levels of thiamine (Vitamin B1). No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 10, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 10, 2018 Category: American Health Source Type: news

Planmed gets FDA clearance for new Verity CBCT features
The U.S. Food and Drug Administration (FDA) has cleared the latest features...Read more on AuntMinnie.comRelated Reading: Health Canada clears Planmed's Clarity systems Planmed adds features to its Verity CBCT scanner FDA clears Planmed's 2D digital mammography system FDA clears Planmed's Verity for maxillofacial imaging Planmed inks Verity distribution pact (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 7, 2018 Category: Radiology Source Type: news

iCAD gets FDA nod for ProFound AI software for DBT
iCAD has received U.S. Food and Drug Administration (FDA) clearance for its...Read more on AuntMinnie.comRelated Reading: iCAD touts clinical results with Xoft Axxent brachytherapy iCAD highlights study results of DBT software FDA OKs iCAD's breast density AI software iCAD touts study on radiation therapy savings iCAD scores Chinese OK for balloon applicators (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 7, 2018 Category: Radiology Source Type: news

EKG, Other Heart Health Features Come to Apple Watch
NEW YORK (AP) — Apple Watch is now fulfilling its promise to let people take EKGs of their heart and notify them of any irregular heartbeat. Apple announced the heart features in September, but didn't make them available until Thursday. The new features have been given clearance by the U.S. Food and Drug Administration and are for U.S. customers only. Related JEMS Article: The iBeat Is a ‘Smart’ Watch, But It Can’t ‘Save Your Life’ The watch can intermittently check the wearer's heart rhythm in the background and send a notification if it detects irregular heart rhythm. That can poi...
Source: JEMS Patient Care - December 7, 2018 Category: Emergency Medicine Authors: Associated Press Tags: Cardiac & Resuscitation News Source Type: news

EKG, Other Heart Health Features Come to Apple Watch
NEW YORK (AP) — Apple Watch is now fulfilling its promise to let people take EKGs of their heart and notify them of any irregular heartbeat. Apple announced the heart features in September, but didn't make them available until Thursday. The new features have been given clearance by the U.S. Food and Drug Administration and are for U.S. customers only. Related JEMS Article: The iBeat Is a ‘Smart’ Watch, But It Can’t ‘Save Your Life’ The watch can intermittently check the wearer's heart rhythm in the background and send a notification if it detects irregular heart rhythm. That can poi...
Source: JEMS: Journal of Emergency Medical Services News - December 7, 2018 Category: Emergency Medicine Authors: Associated Press Tags: Cardiac & Resuscitation News Source Type: news

Fine Land Corp Issues Allergy Alert on Undeclared Milk Allergens in “Meiqili Durian Candy”
Fine Land Corp is recalling it ’s 12 ounce (340 g) Meiqili Durian Candy in plastic bag with clear window because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life – threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 7, 2018 Category: Food Science Source Type: news

Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
RALEIGH, N.C., Dec. 7, 2018 -- (Healthcare Sales & Marketing Network) -- Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Int... Devices, Interventional, FDA Contego Medical, Vanguard IEP, Peripheral, Angioplasty, embolic protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 7, 2018 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer
Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. (Source: Roche Media News)
Source: Roche Media News - December 7, 2018 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer
Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. (Source: Roche Investor Update)
Source: Roche Investor Update - December 7, 2018 Category: Pharmaceuticals Source Type: news

Accra Super Market Issues Allergy Alert On Undeclared Peanuts In'Suya Barbecue Seasoning '
Accra Super Market of Worcester MA, is recalling 0.53 lbs packages of " Suya Barbecue Seasoning " because it may contain undeclared peanuts. People who have allergies to peanuts 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 - December 7, 2018 Category: Food Science Source Type: news

Roche's lung cancer combo treatment wins FDA approval
Swiss drugmaker Roche Holding AG said on Thursday that its Tecentriq immunotherapy in combination with chemotherapy was approved by the U.S. Food and Drug Administration as a first-line treatment for a form of lung cancer. (Source: Reuters: Health)
Source: Reuters: Health - December 6, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels
Following a recall by Sunshine Mills, Inc., the Kroger Louisville division announced it has removed from sale Abound Chicken& Brown Rice Recipe dog food produced by the supplier. The dog food was sold in one Kroger store located at 2440 Bardstown Road in Louisville, KY. Only Abound Chicken& Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may cause renal failure. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: Food Science Source Type: news

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels
Following a recall by Sunshine Mills, Inc., King Soopers announced it has removed from sale Abound Chicken& Brown Rice Recipe dog food produced by Sunshine Mills, Inc. sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. Only Abound Chicken& Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may cause renal failure. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: Food Science Source Type: news

Danone North America Issues Allergy Alert and Recall for Light & Fit Greek Crunch S ’mores Flavor
Danone North America is voluntarily recalling 3,521 cases of Light& Fit ® Greek Crunch Nonfat Yogurt& Toppings S ’Mores Flavor sold in the United States with an expiration date of December 30, 2018 and UPC of 36632 03825. It was discovered that some of the toppers sold on the product contain peanuts and are improperly labeled. People who have an allergy to peanuts 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 - December 6, 2018 Category: Food Science Source Type: news

Tris Pharma Issues Voluntary Nationwide Recall of Infants ’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen
Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants ’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: Food Science Source Type: news

Tris Pharma Issues Voluntary Nationwide Recall of Infants ’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen
Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants ’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’ s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’ s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’ s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: American Health Source Type: news

Country Flavor Inc Issues Alert on Undeclared Sulfites In " Best Taste Brand Dried Bamboo Shoot "
Country Favor Inc. of Maspeth, New York is recalling its 12 ounce packages of " Best Taste Brand DRIED BAMBOO SHOOT " food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 6, 2018 Category: Food Science Source Type: news

LED Medical Diagnostics ’ Subsidiary Apteryx, Inc. Announces FDA Approval of New 3D Module for Its XVWeb Cloud Imaging Service
XVWeb 3D Expands Software-as-a-Service Functionality to Include 3D Cone Beam Computed Tomography (CBCT) Data Sets Vancouver, BC – December 6, 2018 –LED Medical Diagnostics Inc. ( " LED Medical " or " the Company " ) subsidiary Apteryx, Inc. ( “Apteryx”) today announced their XVWeb 3D imaging service has received approval by the United States Food and Drug Administration. XVWeb 3D is uniquely designed to provide additional functionality to its XVWeb service platform by providing dental professionals with a wide variety of visualizatio n and diagnostic capabilities for CBCT DI...
Source: Dental Technology Blog - December 6, 2018 Category: Dentistry Source Type: news

FDA grants priority review to Roche's Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES - SCLC). (Source: World Pharma News)
Source: World Pharma News - December 6, 2018 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible < em > Listeria monocytogenes < /em > Health Risk
Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 5, 2018 Category: Food Science Source Type: news

Biotech to add local jobs to after FDA approval
After getting the green light from the U.S. Food and Drug Administration, Catalyst Pharmaceuticals said it will add 28 full-time employees to sell and market its newest drug. About half of those jobs will be based in Coral Gables, Catalyst (Nasdaq: CPRX) CEO Patrick J. McEnany said. The new hires are part of the biopharmaceutical company's commercialization plan for Firdapse, which the FDA approved for sale last week. It's expected to be commercially available in the first quarter of 2019. Firdapse… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 5, 2018 Category: Biotechnology Authors: Emon Reiser Source Type: news

FDA floats changes to De Novo pathway
The FDA this week published a new proposed rule looking to establish procedures and criteria for its De Novo certification pathway. If the rule is finalized, it would establish classifications for new types of medical devices and provide guidelines for the de novo classification process. The proposed rule would also establish requirements for the formatting and content of de novo requests, according to the FDA release, and would clarify the agency’s criteria for approval, declining and withdrawing such requests. The pathway, originally created through the Food and Drug Administration Modernization Act allows new, low...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Federal officials call out FDA over lapses in rare-disease drug approval
The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday. (Source: CNN.com - Health)
Source: CNN.com - Health - December 5, 2018 Category: Consumer Health News Source Type: news

U.S. FDA removes safety warning from Smith & Nephew's diabetic gel
British medical products maker Smith& Nephew said on Wednesday that the U.S. Food and Drug Administration (FDA) had approved the removal of a safety warning on its treatment for lower extremity diabetic neuropathic ulcers. (Source: Reuters: Health)
Source: Reuters: Health - December 5, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA grants priority review to Roche ’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES - SCLC). (Source: Roche Media News)
Source: Roche Media News - December 5, 2018 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES - SCLC). (Source: Roche Investor Update)
Source: Roche Investor Update - December 5, 2018 Category: Pharmaceuticals Source Type: news

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk
Chukar Cherries of Prosser, WA expands a recall on Ultra Dark Chocolate product because it may contain 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 these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 5, 2018 Category: Food Science Source Type: news

Hiland Dairy Announces Voluntary Recall of Hiland Dairy Half-Gallon Whole Chocolate Milk
Hiland Dairy is announcing a voluntary recall of half-gallon premium whole milk chocolate that is produced at the Kansas City, Missouri facility, over concerns the products may contain eggnog that could affect those individuals that have sensitivity to egg allergens. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 5, 2018 Category: Food Science Source Type: news

Is acetaminophen the most dangerous OTC pain reliever of all?
(Natural News) If a natural health product or supplement was known to cause 56,000 emergency room visits, over 100,000 calls to poison control centers, 26,000 hospitalizations and more than 450 deaths each year, what are the chances that the U.S. Food and Drug Administration (FDA) would allow its manufacturer to continue distribution? The answer is... (Source: NaturalNews.com)
Source: NaturalNews.com - December 4, 2018 Category: Consumer Health News Source Type: news

New Drug Treats Dogs Scared by Loud Noises
Pexion (imepitoin tablets), just approved by the Food and Drug Administration, is for dogs scared by loud noises such as fireworks, street/traffic racket, and gun shots. (Source: WebMD Health)
Source: WebMD Health - December 4, 2018 Category: Consumer Health News Source Type: news

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). (Source: Food a...
Source: Food and Drug Administration - December 4, 2018 Category: Food Science Source Type: news

FDA Wants to Change the De Novo Pathway
Last week, FDA revealed plans to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. This week, the agency has turned its attention to the de novo pathway for medical devices. The de novo pathway is used for the review of novel, low to moderate risk devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no existing predicate to use to determine substantial equivalence. According to FDA Commissioner Scott Go...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Business Source Type: news

FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
(Source: Food and Drug Administration)
Source: Food and Drug Administration - December 4, 2018 Category: American Health Source Type: news

FDA grants special designation for Bayer AI software
Bayer announced in a release that the U.S. Food and Drug Administration granted a breakthrough device designation for an AI pattern recognition software that it is jointly developing with Merck. The software is designed for the treatment of chronic thromboembolic Pulmonary Hypertension (CTEPH), a rare form of pulmonary hypertension that is often difficult to diagnose because symptoms often mimic those of asthma or chronic obstructive pulmonary disease (COPD). Working together, Bayer and Merck have… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - December 4, 2018 Category: Health Management Authors: Mike Larson Source Type: news

Toxic Amounts of Vitamin D Spur Dog Food Recall
TUESDAY, Dec. 4, 2018 -- Eight brands of dry dog food have been recalled because of potentially deadly amounts of vitamin D, the U.S. Food and Drug Administration says. Vitamin D is an important nutrient for dogs. But too much can cause symptoms... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 4, 2018 Category: General Medicine Source Type: news

FDA Grants Breakthrough Device Designation to Artificial Intelligence Software for CTEPH Pattern Recognition from Bayer and MSD
Bayer announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA). (Source: eHealth News EU)
Source: eHealth News EU - December 4, 2018 Category: Information Technology Tags: Featured Industry Business and Industry Source Type: news

Health Tip: What Causes Memory Loss?
-- Mild memory issues are common from time to time, especially as you age, the U.S. Food and Drug Administration says. The agency says anything that affects the processes of thinking and learning can affect memory. It mentions these common causes... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 4, 2018 Category: General Medicine Source Type: news

FDA recognizes NHGRI's ClinGen, dataset that ties genetic variants to disease
For the first time, the Food and Drug Administration has formally recognized a public dataset of genetic variants and their relationship to disease to help accelerate the development of reliable genetic tests. Genetic test makers, including those using next-gen sequencing, can use genetic variant information in the Clinical Genome Resource (ClinGen) to support clinical validity in premarket submissions to FDA. ClinGen is administered by the National Human Genome Research Institute, part of the National Institutes of Health, and is available viaClinVar. (Source: NHGRI Homepage Highlights)
Source: NHGRI Homepage Highlights - December 4, 2018 Category: Genetics & Stem Cells Source Type: news

Aclaris completes $65M deal for rosacea treatment
Malvern-based Aclaris  Therapeutics Inc. completed its previously announced $65 million acquisition of Rhofade, a rosacea treatment, from Allergan. The Food and Drug Administration approved Rhofade, a cream, last year as topical treatment of persistent facial erythema or redness associated with rosacea in adults. “ An estimated 16 million American adults have rosacea, yet only a small fraction of that number seeks professional care," said Dr. Neal Walker, president and CEO of Aclaris (NASDAQ:… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 3, 2018 Category: Biotechnology Authors: John George Source Type: news

Aclaris completes $65M deal for rosacea treatment
Malvern-based Aclaris  Therapeutics Inc. completed its previously announced $65 million acquisition of Rhofade, a rosacea treatment, from Allergan. The Food and Drug Administration approved Rhofade, a cream, last year as topical treatment of persistent facial erythema or redness associated with rosacea in adults. “ An estimated 16 million American adults have rosacea, yet only a small fraction of that number seeks professional care," said Dr. Neal Walker, president and CEO of Aclaris (NASDAQ:… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 3, 2018 Category: Pharmaceuticals Authors: John George Source Type: news

FDA grants breakthrough device designation to artificial intelligence software for CTEPH pattern recognition from Bayer and MSD
Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA). (Source: World Pharma News)
Source: World Pharma News - December 3, 2018 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news

Nigeria: NAFDAC Destroys N3 Billion Substandard Medicines in One Year
[Daily Trust] The National Agency for Food and Drug Administration and Control (NAFDAC) has seized and destroyed substandard and falsified medicines worth three billion naira within the last one year. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - December 3, 2018 Category: African Health Source Type: news