Tuesday, January 31, 2012

Counterfeit Medicine - On the FDA Website

Counterfeit drugs
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The FDA has a nice constellation of items and articles related to counterfeit medicine.

Counterfeit Medicine - US FDA Website:
"Counterfeit Medicine - Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health. 
FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits."
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Free information and resources about counterfeit medicine:
US FDA Website - Counterfeit Medicine

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Monday, January 30, 2012

FDA Supplement Guidance Not Strict Enough, MD Says

This is pretty controversial stuff, as the dietary supplement industry largely opposes the draft regulation

Medical News: FDA Supplement Guidance Not Strict Enough, MD Says - in Public Health and Policy, FDA General from MedPage Today:

"An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.  
More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance. 
But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece."
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Read more about this:
FDA Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

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Wednesday, January 25, 2012

FDA issues first social media rules for drug companies

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again. 
The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."
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Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)

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Sunday, January 22, 2012

Pot-based Prescription Drug Looks For FDA OK

This caught my eye. I had no idea there were products in the pipeline.

Pot-based Prescription Drug Looks For FDA OK | Fox News:
"A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents — a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013.

Sativex contains marijuana's two best known components — delta 9-THC and cannabidiol — and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis."
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Saturday, January 21, 2012

New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting

This just recently published by the FDA:

FDA Guidances (Drugs); Newly Added Guidance Documents:
Chemistry, Manufacturing, and Controls (CMC): Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB - Final Guidance 10/11/11)
'via Blog this'

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Friday, January 20, 2012

Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA

Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA:

"Issued by the US Government Accountability Office, the new report says up to 40 percent of all pharmaceuticals sold in the US are actually manufactured overseas in countries like India and China. A whopping 80 percent of all ingredients used to manufacture drugs, including those manufactured in the US, reportedly come from overseas as well. And the FDA has inspected a mere 11 percent of all foreign drug manufacturing facilities, as opposed to the 40 percent it has inspected domestically."
'via Blog this'

Drug lobby wants clearer FDA rules for diet pills

Drug lobby wants clearer FDA rules for diet pills | Reuters:

"Over the past year, the FDA has drawn fire from some manufacturers for being too cautious in reviewing medical products, hindering U.S. innovation.

They point to obesity drugs, where Arena Pharmaceuticals, Orexigen Therapeutics and Vivus have hit roadblocks in gaining approval for their diet pills because of potential safety concerns."
'via Blog this'

Thursday, January 19, 2012

FDA to weigh safety of tobacco lozenges, strips

I have mixed feelings. I know that I strongly dislike being around cigarette smoke. And I also understand the dangers and potential poisoning risks that these products pose.

FDA to weigh safety of tobacco lozenges, strips - USATODAY.com:
"Dissolvables" are flavored mints, strips and sticks of smokeless tobacco. These products are not stop-smoking aids. Instead, they are designed to allow people to satisfy their cravings for nicotine in places where smoking is banned."
'via Blog this'

US counterfeit drug seizures up 200 per cent in 2011

SecuringPharma - US counterfeit drug seizures up 200 per cent in 2011:

"China remained the primary source of counterfeit goods across all categories, representing 62 per cent of all seizures by value, with the value of pharmaceutical seizures from China increasing by more than $4.3m and the value of perfume seizures up $7m on the prior year.

Meanwhile, India and Pakistan both featured in the top 10 source countries in 2011, mainly due to seizures of counterfeit pharmaceuticals. Pharmaceutical seizures accounted for 86 per cent of the value of seizures from India and 85 per cent from Pakistan, said the CBP.

The top 10 source countries - in descending order - were: China; Hong Kong; India; Pakistan; Taiwan; Switzerland; Malaysia; South Korea; UK; and Mexico."
'via Blog this

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America Is Drunk

America Is Drunk | Fox News:

"According to the Centers for Disease Control, we’re becoming a nation of drunks. Booze hounds on benders.

New data reveals that one in every six Americans downs eight mixed drinks within a few hours, four times a month. Twenty-eight percent of young people between the ages of 18 and 24 binge-drink five times a month, putting away seven drinks in one sitting. And 13 percent of those between the ages of 45 and 65 binge drink five times a month, too."
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Wednesday, January 18, 2012

FDA Inspection Preparation

Don't get surprised!  Prepare yourself well in advance of an FDA inspection.

But if you should find yourself on the brink of one in a week or so, here's something helpful:
Rapid Deployment Tips to Prepare for an Inspection Quickly by John Avellanet (PDF)

If you're not so much in a rush, then invest some time in getting prepared.

You might be interested in:
Surviving an FDA Inspection - a live onsite training class

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Tuesday, January 17, 2012

FDA Says Drug Shortages Raise Risk of Cancer Counterfeits

The FDA published this notice. Looks like drug shortages are opening doors for bad actors to take advantage of the situation.

FDA Notifies Health Care Providers about the Risks of Purchasing Unapproved Injectable Cancer Medications from Unlicensed Sources
Current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients. Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States (U.S.).
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Monday, January 16, 2012

College-age adults average 9 alcoholic beverages when they binge drink

Alcoholic beverages
Image via Wikipedia
This was somewhat thought-provoking. . .  if you go to a dinner party and have 4-5 or more glasses of wine over at least that number of hours, does that also qualify as binge drinking?  hmmm

College-age adults average 9 alcoholic beverages when they binge drink, CDC report says - The Washington Post:
"College-age drinkers average nine drinks when they get drunk, government health officials said Tuesday. That surprising statistic is part of a new report highlighting the dangers of binge drinking, which usually means four to five drinks at a time. Overall, about 1 in 6 U.S. adults surveyed said they had binged on alcohol at least once in the previous month, though it was more than 1 in 4 for those ages 18 to 34."
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Wednesday, January 11, 2012

Food Facility Audits Largely Ignore FDA Guidance

Food Facility Audits Largely Ignore FDA Guidance | News | Manufacturing.net:

"The present audit system is fraught with conflicts and is designed not to find safety problems, but to keep food — regardless of quality — flowing from farm to fork," he said"
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MediBabble - Medical Translation at Your Fingertips

I just learned about this the other day, and thought I'd share this with everybody.

MediBabble in the Press:
"MediBabble is an impressively powerful and comprehensive (and free!) mobile medical interpretation tool with great utility for clinical settings — a true must-have for any individual involved with health care delivery!"
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Monday, January 9, 2012

FDA Audit Preparation

Photograph of the Taxus drug-eluting stent, fr...
Image via Wikipedia
The folks from Emergo Group have a very nice outline of how to think and approach FDA inspection readiness, before the FDA actually shows up at your door.

Preparation for an FDA Quality System Audit - from Emergo Group:
"In order to meet US Food and Drug Administration (FDA) requirements, medical device manufacturers active in the US market must undergo FDA audits of their quality management systems to demonstrate compliance with Quality System Regulation 21 CFR Part 820, also known as Good Manufacturing Practice (GMP)."
'via Blog this'

You might also be interested in:
Surviving an FDA Inspection by SkillsPlus International Inc.

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Saturday, January 7, 2012

FDA Antibiotic Ban is Too Little, Too Late

Antibiotic Ban is Too Little, Too Late - NYTimes.com:

"To recap, the F.D.A. will partially ban a disappearing family of antibiotics that is relatively non-existent in animal agriculture and that the meat industry does not rely upon. Not exactly a bold move. Kind of like protecting less than 1 percent of the acreage in the rainforest or 1 percent of the fish in the sea while allowing producers to devastate the rest, and patting yourself on the back to boot."
'via Blog this'

Sunday, January 1, 2012

27 Hot Drugs Facing FDA Approval in 2012

27 Hot Drugs Facing FDA Approval in 2012 - TheStreet:

"Here's an updated look at the biotech and pharmaceutical companies with pending FDA drug approval decisions in 2012."
'via Blog this'

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