Role Play – A Tale of Two Cousins  

This role play enlightened about how sensitive clinical trials are, and focused on the real life story of two cousins (Brandon and Thomas) in lethal stages of melanoma. A tale of two cousins came into the media’s light due to the fact that were two drugs with different routes of administration that were used to treat melanoma, clinical trials were conducted to demonstrate the efficacy of drug PLX-4032 (wonder drug) in comparison to I.V Dacarbazine, a drug that already existed in the market and showed extremely poor results. In addition, the two cousins Brandon and Thomas were recruited into phase 3 of these trials, which were controlled and randomized, where it claimed the life of one of the cousins. The control arm (Brandon) was given I.V. Dacarbazine and the treatment arm (Thomas) was given PLX-4032 which was found to be effective in shrinking tumor sizes. The control arm faced death (Brandon) due to the ineffectiveness of the medicine. People concerned with the trial should be prudent and careful when designing the clinical trials. This created an uproar of ethical issues which involved the negligence of subjects when their quality of life should have been focused on. 

Update on ANZTPA Medical Device Regulatory Harmonization in Australia and New Zealand

Medical device market regulators in Australia and New Zealand have implemented a series of projects involving adverse event notification, device recall information and quality system inspections as part of the countries’ long-term effort to establish a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

• First, the Australian Therapeutic Goods Administration [TGA] and New Zealand's Medsafe have set up a Joint Adverse Event Notifications System (JAENS) to inform each other of adverse events occurring in their respective markets.
• Second, the two regulators have begun an early-warning system to alert healthcare providers in both countries of safety issues involving drugs and medical devices.
• Third, the TGA and Medsafe have launched a Recall Portal that provides publically available recall action data on devices and drugs in Australia and New Zealand.
• Fourth, the regulators have developed a joint capability for Good Manufacturing Practice inspections in both markets. However, the TGA and Medsafe are still working on final development and implementation of a single GMP Inspection and Licensing system expected to go live once the ANZTPA is fully operational.

FDA Approves First Device to Treat Migraine Pain

“Millions of people suffer from migraines, and this new device represents a new treatment option for some patients".

The device is used by prescription after onset of pain associated with migraine with aura. Using both hands, the patient holds the device to the back of the head and, pressing a button, releases a pulse of magnetic energy that stimulates the occipital cortex, stopping or reducing the pain associated with this type of migraine. The recommended daily usage of the device is not to exceed 1 treatment in 24 hours.

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.