Editor-in-Chief eMediNexus – Dr KK Aggarwal
27th June 2019

FDA approved vs FDA cleared

Dr KK Aggarwal, Recipient of Padma Shri

(CNET Excerpts): The FDA (DCGI and FSSAI) is responsible for telling us which foods, drugs and medical devices are safe for us to use.

There is a big distinction between a drug or medical device that has been FDA approved and those that are FDA cleared. It's important to understand the difference.

What does the FDA regulate?

  • Prescription drugs for humans and animals
  • Over-the-counter drugs
  • Biologics (e.g. vaccines, blood products, biotechnology products and gene therapy) ...read more

FDA cautions about mortality risk with fecal transplant

Dr KK Aggarwal, Recipient of Padma Shri

As per FDA two patients received donated stool that had not been screened for drug-resistant germs, leading it to halt clinical trials until researchers prove proper testing procedures are in place.

Both transplants came from the same donor's fecal matter. The report does not state whether the fecal material was given in liquid form as an infusion into the digestive tract or swallowed as pills.

Other samples from the same donor were tested after the patients got sick. The samples were found to harbor the same dangerous germs found in the patients, known as multi-drug-resistant organisms. They were E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase,...read more

Video Of The Day : All about liver imaging
Practice Updates

Health services not included in Consumer Protection Act but are also not excluded

Under the CPA, definition, 2 (o) "service" means service of any description which is made avail-able to potential users and includes, but not limited to, the provision of facilities in connection with banking, financing insurance, transport, processing, supply of electrical or other energy, board or lodging or both, housing construction, entertainment, amusement or the purveying of news or other information, but does not include the rendering of any service free of charge or under a contract of personal service;... read more

Instead of condemning they should be appreciated

मरने के बाद मरीज का करा दिया एक्सरे,
11 डॉक्टरों को नोटिस: मेडिकल अस्पताल में भर्ती एक मरीज की हालत में सुधार आने के बाद अचानक दम तोड़ जाने पर मौत के कारण जानने के लिए लाश काएक्सरे कराना ईएमओ और 10 डॉक्टरों को भारी पड़ गया। मामला जब प्रिंसिपल के संज्ञान में आया... read more

Bihar Encephalitis Mortality Rate Down Due Thanks To Centre: Union Health Minister

NEW DELHI: The mortality rate due to Acute Encephalitis Syndrome (AES) cases in Bihar has come down significantly due to strategic interventions made by the central government, Union Health Minister Harsh Vardhan said Tuesday.... read more

Uganda's groundwork in preparedness bodes well for stopping Ebola's spread within its borders

As Uganda steps up its response to its first confirmed Ebola cases, preparations made since the outbreak began in the neighboring Democratic Republic of the Congo (DRC) are proving crucial to containing the disease.... read more

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal... read more

Prostate cancer: New urine test hope

An experimental new urine test can reveal if men with early prostate cancer will probably need aggressive therapy or can be left untreated but monitored, UK researchers say. Current PSA blood tests cannot do this, meaning many men experience unnecessary worry, investigations and treatment.... read more

Higher Obstetric Risks in IVF With More-Developed Embryos

Transfer of embryos cultured until the blastocyst phase during in vitro fertilization (IVF) was associated with an increased risk of obstetric complications and twin births, a large retrospective cohort study found.... read more

Medical Voice

Do these 7 things today, to save your sight tomorrow, says AAO to young adults

The American Academy of Ophthalmology (AAO) urges young adults to protect their eyes to prevent vision loss in the future. It recommends adults under age 40 have a comprehensive medical eye exam every 5 to 10 years.

1.Wear sunglasses(even when it's cloudy). Long-term exposure to the sun without proper protection can increase the risk of eye disease, including cataract,... read more

IDEJ Update

Indian Diabetes Educator Journal (IDEJ), 1st of its kind in India aims to keep the members of diabetes care team abreast with concepts of DSME (Diabetes self-management education) and DSMS (Diabetes self-management support). IDEJ has set a new benchmark in educating the diabetes educators about evolving the concept of DSME- reaching to more than 25000 through Digital and Print Medium..... read more

eMedi Humor
Medicolegal Corner
eMedi Quiz
1. Temperature.
2. Partial pressure of CO2
3. 2,3 DPG concentration.
4. Oxygen affinity of hemoglobin.
Lifestyle Updates
Inspirational Story 1: The Doctor and the Father
Inspirational Story 2: The Power of Good Words
"To watch 1500+ such videos, please visit www.medtalks.in"
Compassion, care, punctuality, and ethics are the hallmarks of a good doctor
There is a need to bring back family physicians for better health outcomes
New Delhi, 26 June 2019: Research indicates that less than one percent physician communications with patients are expressions of empathy or compassion. It also indicates that healthcare providers who practice compassion and have empathy for patients have less burnout, more resilience and superior well-being. Understanding the socio-economic circumstances of a patient can have better outcomes. The need of the hour is to raise awareness on the importance of a family physician in this regard.

A physician must be aware of the social determinants of health, that is, the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. Family physicians address the social determinants of health.

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