Clinical research is the next big thing in developing India

By 2020, India will be among the top five countries for clinical research. It is one of the fastest growing sectors.

Currently, India ranks 14 in the clinical research market, but will soon be among the top. It's the next big thing in India. Other leading Asian countries are China and Korea. According to ISCR, the economic slowdown affected the industry in the initial four months. The industry has picked up over the past nine months.

Update on US FDA Unique Device Identification Submission System

The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.

Manufacturers with US medical device market authorization are required to submit device identification data into a Global Unique Device Identification Database (GUDID) managed by the FDA. Firms now have two options for submitting information to the GUDID: a GUDID Web Interface that requires users to set up GUDID accounts, and an HL7 SPL option for submitting device information via xml file one record at a time.

Submitting a device information record using the HL7 SP option requires firms to establish GUDID accounts and send xml files through the FDA Electronic Submissions Gateway.

Oxytocin 'Normalizes' Social Deficits in Kids With Autism

A single dose of the hormone oxytocin administered via nasal spray enhances brain activity in key regions, temporarily improving social information processing in children with autism spectrum disorder (ASD).

Smoking Pot May Double Risk for Stillbirth

Cannabis (tetrahydrocannabinolic acid), smoking, illicit drug use, and secondhand smoke exposure are linked to increased risk for stillbirth twofold. Secondhand smoke alone also almost doubled the odds of stillbirth.

FDA and EMEA approve of Game Changer Sofosbuvir 

   

 Sofosbuvir is a first-in-class polymerase inhibitor that allows for   all-oral, interferon-free therapy for some patients with hepatitis  C and reduced treatment time for most.

The US Food and Drug Administration (FDA) has approved the first-in-kind nuceotide analog inhibitor sofosbuvir (Sovaldi, Gilead Sciences, Inc) for the treatment of adults with chronic hepatitis C virus (HCV) infection, a widely anticipated move that is expected to dramatically improve outcomes for many patients.

The European Medicines Agency's Committee for Medicinal Products for Human use (CHMP) has recommended granting a marketing authorisation for Sovaldi (sofosbuvir), for use 'in combination with other medicinal products for the treatment of chronic (long-term) hepatitis C in adults'.

Clobazam (Onfi) Can Cause Serious Skin Reactions, FDA Warns 

The antiseizure drug clobazam (Onfi, Lundbeck) can trigger rare but potentially fatal skin reactions, the US Food and Drug Administration (FDA) announced today.

For clobazam, the skin reactions to watch for are Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Patients taking clobazam can experience these disorders at any time, but the risk goes up during the first 8 weeks of treatment or when treatment resumes after it was stopped. All the cases of these 2 adverse events identified by the FDA landed patients in the hospital, with 1 patient going blind and another dying.

Oral Cancer Screening

Squamous cell carcinoma accounts for 90% of all cases of oral cavity and pharyngeal cancer. More than half of persons with oral and pharyngeal cancer have regional or distant metastases when they are first diagnosed. The USPSTF therefore stated that screening for oral cancer may be helpful if potentially malignant disorders can be identified earlier and treated successfully.

ORAL CANCER SCREENING METHODS