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Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority…These products, that combine drugs, devices, and/or biological product ("constituent parts") with one another… Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas….we’re taking a number of steps to clarify regulatory requirements and improve our internal processes and IT systems.

• Issuing more guidance for review of combination products (e.g., our pending draft guidance document on human factors);
• Enhancing and simplifying data access and sharing for internal staff;
• Making it easier for staff to request and monitor inter-center consults;
• Updating and maintaining our internal contact directory for experts to review a combination product; and
• Improving our internal standard operating procedures for premarket reviews and compliance activities.

Valeant Pharmaceuticals International Inc, under fire for price increases of its two heart drugs, said it was subpoenaed by U.S. prosecutors on its pricing, drug distribution and patient assistance programs…. The company, which came under attack from Democratic lawmakers in late September over "massive" price increases, said it was reviewing subpoenas from the offices of attorneys for the District of Massachusetts and the Southern District of New York…Valeant had tripled Isuprel's price and raised Nitropress price more than six times after buying them in February.

Jay Greco, RPh, owner of Jersey Shore Pharmacy, discusses significant issues causing difficulties for specialty pharmacy.

This infographic from the 2015 HIMSS Cybersecurity Survey shows the greatest areas of improvement in cybersecurity that healthcare organizations were able to achieve this year.

Dietary supplements - those "all natural" products people consume for weight loss, extra energy or to self-treat various conditions - send 23,000 people…to the emergency room…each year, according to a new estimate…9 percent require hospitalization…new study "illustrates the idea that something that's 'natural' is not necessarily safe, and these products do not come without risk,"…a trade association that represents supplement manufacturers…reacted…arguing that the results…reinforce that dietary supplements are safe products…Congress has thwarted attempts to strictly regulate the $14.8 billion industry, where products are often marketed as if they were drugs but safety testing and FDA approval are not required. Only if a product is later found to be unsafe can the agency ban it…The number of emergency department visits attributed to supplement-related adverse events…is probably an underestimation, since supplement use is underreported by patients, and physicians may not identify adverse events associated with supplements as often as they do those associated with pharmaceuticals…

The biotechnology sector has taken a big dive in recent weeks, mostly for reasons that have more to do with political posturing than with industry fundamentals...Let's examine why biotech's plummet happened -- and explore two growth-and-income stocks that are poised to soar because of it.

..majority of healthcare professionals in the UK support greater transparency on payments received from pharmaceutical companies, but some feel the move could make working with the industry more difficult…87% agreed that payments from pharma to individually named healthcare professionals should be disclosed…32% of healthcare professionals surveyed feel the disclosure of individual payments is unnecessary, while 26% believe that doing so will adversely affect medical innovation… survey results come as pharmaceutical companies gear up to unveil payments and other ‘transfers of value’ …on a publicly accessible database…the new ‘Sunshine rule’, which comes into force next year, NHS staff who fail to disclose perks received from drug companies could face being disciplined, dismissed or even sent to jail for breach of the Bribery Act.

…health authorities warned consumers recently about dangers of so-called herbal Viagra, non-prescription products sold to enhance sexual performance, reportedly used by former professional basketball player Lamar Odom, who is in critical condition in a Las Vegas hospital...unregulated sex performance supplement could cause a severe reaction…You can get into trouble because some of these remedies for sexual prowess are stimulants…taken in sufficient quantity, can cause problems with your cardiovascular system…Food and Drug Administration has found that some supplements sold as herbal alternatives to Viagra or Cialis contain the active ingredients of those drugs…falsely marketed as "dietary supplements" that promise to enhance sexual performance are "a risky proposition."..We've seen pills, coffees, chewing gum and dissolvable oral strips that contain hidden drug ingredients or untested chemicals…

Ranchi: Around 18,000 licensed chemists of Jharkhand participated in the nationwide strike of drug sellers on Wednesday to protest against the growing online sale of medicines in the country, posing problems for customers…Private drug stores in Ranchi and across 24 districts kept their shutters down while the Jharkhand Chemists and Druggists Association, the umbrella organization of drug sellers in the state, kept a handful of medicine shops operational to sell emergency medicines to consumers. They demanded the Union government check e-commerce in medicine.

DNA4Life announced the…launch of its Pharmacogenetic Report, which will be available…to patients… DNA4Life’s test analyzes a person’s DNA to predict how they will respond to 120 commonly prescribed medication. One of the main goals of pharmacogenetics is avoiding adverse drug reaction…"Our differentiated and more comprehensive analysis will assist healthcare professionals in customizing a personalized treatment plan for their patients…particularly those being treated for chronic conditions, like high cholesterol, depression, ADHD or pain."