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Japan's Ministry of Health, Labour and Welfare received around 50 formal applications and has cleared screening for the "sakigake" fast-track drug and device review process before the Pharmaceuticals and Medical Devices Agency,… The "sakigake designation system" is aimed at expediting the review of innovative drugs, regenerative medicines and devices developed in Japan earlier than the rest of the world. This includes prioritized consultations and priority review status….products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world,…

Mergers will benefit consumers, CEOs of both companies tell Senate panel…chief executives of Aetna Inc. and Anthem Inc. defended their merger deals before a Senate subcommittee, facing sharply critical testimony that raised questions about the impact of health-insurance consolidation…Aetna is seeking to acquire Humana Inc.,..focused largely on the private Medicare plans known as Medicare Advantage. Anthem aims to take over Cigna Corp…The two deals together would shrink the top five health insurers to a big three, each with annual revenue of more than $100 billion. The third player would be UnitedHealth Group Inc.

United States is the only country with a strong pharmaceutical regulatory infrastructure that allows direct-to-consumer advertising of prescription drugs in print, broadcast, and electronic media. U.S. consumers are accustomed to full-page ads in newspapers and magazines detailing a drug's benefits… That may soon change, however, as the Food and Drug Administration moves to enact new regulations regarding risk communication in DTCA…. responds to mounting research showing that reprinting highly technical package inserts in print ads does very little to communicate risks to consumers. The goal is to communicate those risks in a new vernacular.

Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough,…FDA uses the term...for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims…the...Safety and Innovation Act (2012),..allows the FDA to give breakthrough designation to any drug treating a serious or life-threatening condition that "may demonstrate a substantial improvement over existing therapies"…"Breakthrough" is an aspirational term, chosen for the 2012 act to help expedite the new drug approval process,...

Aims for a 'more patient-centered medical product development and assessment process'…As healthcare enters an era in which "patients and their care partners participate actively in decision-making and priority-setting," FDA has launched its first-ever Patient Engagement Advisory Committee…the group will offer perspective...on issues related to regulation of technology and medical devices, and their use by patients. FDA will learn about patient-related topics and better integrate those patient perspectives into its regulatory process.

Walgreen Co.’s persisting failure to remove expired sales tags from its shelves deceives customers and violates a 2014 settlement that sought to resolve the matter in Missouri, the state’s attorney general argued…in asking a state court to punish the pharmacy chain…Attorney General Chris Koster filed court documents asking a judge to hold the nation’s largest pharmacy retailer in contempt of the settlement and issue steeper fines, including up to $5,000 for each expired tag. Koster said that since July, undercover investigators have found a total of more than 1,300 shelf tags displaying sales prices that had expired...

In an extensive interview with Bloomberg BNA, IACP's (International Academy of Compounding Pharmacists)David G. Miller, RPh, Executive Vice President & CEO, discusses concerns over the Drug Quality & Security Act (DQSA), emphasizing the need for clarification over which regulatory authority is responsible for the oversight of compounding pharmacy.

Almost every American will experience an error in diagnosis at some point in life. But the problem has taken a back seat to other patient safety concerns,…The report from a blue-ribbon panel of the Institute of Medicine called for widespread changes in health care to improve diagnoses…Errors in diagnosis — defined as inaccuracies or delays — account for an estimated 10 percent of patient deaths, hundreds of thousands of adverse events in hospitals each year and are a leading cause of paid medical malpractice claims...

September 26th,..local and federal agencies will once again partner together to sponsor the Prescription Drug Round Up event in Washoe County. Since the first event in the fall of 2009, the Round Ups in Washoe County have collected nearly 1.5 million prescription pills. More than 210,000 of those pills were in categories that are commonly diverted and abused, such as painkillers, depressants and stimulants.

Round Up Locations September 26th 10:00am – 2:00pm:

• Raleys - 930 Tahoe Blvd, Incline Village
• Raleys - 18144 Wedge Parkway, Reno
• Walgreens - 10370 N. McCarran Blvd, Reno
• Save Mart– 4995 Kietzke Lane, Reno
• CVS - 680 N. McCarran Blvd, Sparks
• Save Mart- 9750 Pyramid Hwy, Sparks

The drug drop boxes are available during regular business hours at the following locations:

• Reno Police Department – 455 E. 2nd Street, Reno
• Sparks Police Department – 1701 East Prater Way, Sparks
• Washoe County Sheriff’s Office – 911 Parr Blvd., Reno

South African Police shut down three counterfeit drug making plants last weekend in an INTERPOL-co-ordinated operation that seized 150 tonnes of fake medicines…involved thousands of police and customs officials in Angola, Malawi, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe who raided markets, shops, pharmacies and warehouses in addition to the three illicit plants…seized products were illicit and counterfeit antibiotics, painkillers, erectile dysfunction medicines, birth control and anti-malarial medication...Authorities arrested 550 people…also closed 20 illegal pharmacies where the fake drugs were sold.