Friday, June 29, 2012

FDA Consumer Updates - Beware of Online Cancer Fraud

"Anyone who suffers from cancer, or knows someone who does, understands the fear and desperation that can set in," says Gary Coody, R.Ph., the National Health Fraud Coordinator and a Consumer Safety Officer with the Food and Drug Administration's (FDA) Office of Regulatory Affairs. "There can be a great temptation to jump at anything that appears to offer a chance for a cure."


Consumer Updates - Beware of Online Cancer Fraud:

"While health fraud is a cruel form of greed, fraud involving cancer treatments can be particularly heartless—especially because fraudulent information can travel around the Web in an instant."

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Thursday, June 28, 2012

Congress To FDA: Study Nano Safety

The FDA will soon have a new nanotechnology safety program, thanks to language tucked into a massive legislative package that’s on its way to President Obama.

Congress To FDA: Study Nano Safety | New Haven Independent:

"The broader bill deals mainly with prescription drug safety and payments from pharmaceutical companies to fund the FDA’s regulatory efforts. Pryor and Cardin saw an opportunity to attach an idea they introduced last year, which had stalled.

Their proposal creates a “Nanotechnology Regulatory Science Program” within the FDA charged with scrutinizing the safety and efficacy of drugs, medical devices, cosmetics and other products that contain super-small particles. The legislation directs the FDA to both review ongoing academic research on health and safety issues, as well as conduct its own studies and work with other agencies."

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Court Ruling Lets $813 Billion in Higher Taxes Proceed - Pharma, Health, Medical Devices

Court Ruling Lets $813 Billion in Higher Taxes Proceed - Bloomberg:

"The health-care taxes in the law also included industry fees for pharmaceutical makers and health insurers, plus a 2.3 percent excise tax on medical devices that aren’t sold directly to consumers, such as hip implants and cardiac stents.

The House of Representatives voted 270-146 on June 7 to repeal the medical device tax, which is scheduled to take effect in 2013. Combined, those three industry fees and taxes are expected to generate $165 billion, according to the new estimate."

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Monday, June 25, 2012

FAQs: Your Sunscreen Questions. EWG Answers

EWG offers lots of information about sunscreens.  Use the information while we're waiting for FDA-mandated sunscreen labeling.

FAQs: Your Sunscreen Questions. Our Answers. | EWG's Skin Deep® | 2012 Sunscreen Report:

"An ideal sunscreen would block both UVA and UVB rays with active ingredients that do not break down in the sun (so that the product remains effective) and would contain active and inactive ingredients that are proven to be safe for both adults and children. Unfortunately, there is no sunscreen on the U.S. market that meets all these criteria, and no simple way for consumers to know how well a given product stacks up on any of these measures. That’s why EWG created this guide to safer and more effective sunscreens. "

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Sunday, June 24, 2012

New FDA sunscreen label standards delayed until winter


New FDA sunscreen label standards delayed until winter - WMBFNews.com, Myrtle Beach/Florence SC, Weather:

"New standards for the labeling sunscreen, intended to help you identify which will protect you best, won't be going into affect before you hit the sands on your summer vacation.

If you're going to spend a lot of time in the hot sun this summer, you'll have to fend for yourself when it comes to picking sunscreen. The FDA has pushed back the new label standards for six months.

The new standards are supposed to make it easier for you to pick up the best bottle of sunscreen off the shelf. They force companies to make a variety of changes like make all label font sizes to be the same so you won't get distracted by what's in bold."

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Saturday, June 23, 2012

FDA regulators face daunting task as health apps multiply

Jenny Gold reports that, "In fact, there are 40,000 medical applications available for download on smartphones and tablets — and the market is still in its infancy. But that growth is in the cross hairs of new regulatory efforts from the Food and Drug Administration."

FDA regulators face daunting task as health apps multiply – USATODAY.com:

"Franko's goal is to make sure doctors and patients know what they're getting as quickly as possible. "These apps already exist," he says, "and people are using them in hospitals to make medical decisions, but no one knows if they're actually doing what they claim to be doing.""

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This is all about mobile, tablet, digital technologies intersecting the FDA's QSR regulations applicable to medical device manufacturers (i.e., 21 CFR 820).

You might also be interested in:
Essentials for Medical Device Manufacturers - Recommended QSR Training - SkillsPlus Intl Inc.
21 CFR 820 Essential Elements - The Best Online QSR Training - SkillsPlus Intl Inc.

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Wednesday, June 20, 2012

The Cost of Quality Failures - An FDA Response

PharmTech Talk » The Cost of Quality Failures:

"One response from FDA and industry is to better quantify the costs of quality failures: lost revenue, lost jobs, damaged reputations and, in some cases, loss of the company, Woodcock said. FDA also is looking closer at the root causes of failures, which may reflect management inattention, deliberate company decisions to defer investment in modern production facilities, or corporate disregard for the quality department. Companies take calculated risks with such approaches, she said, and should consider whether the savings are worth the cost to the firm. “We need the business side to become convinced that a commitment to quality can avoid costly failures.”"

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Human Errors: Overcoming the Challenges - a popular QSR and GMP training course

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Tuesday, June 19, 2012

Warning: Your “Check CAPA” Light is On - FDA Form 483

Warning: Your “Check CAPA” Light is On | Ask Cato:

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.

"The requirements are summarized as follows:

  1. Analyze processes to identify the root cause of the nonconformance and to proactively identify potential causes of future nonconformance;
  2. Investigate the cause;
  3. Identify actions needed to correct and prevent nonconformance recurrence;
  4. Validate that the CAPA is effective and does not cause unintended adverse effects;
  5. Implement and record changes in procedures to correct and prevent the recurrence of noncompliance;
  6. Ensure direct dissemination of CAPA information to those responsible for assuring product quality to ensure adequate training for preventive actions; and
  7. Submit the relevant documentation on CAPA for management review."
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Root Cause Analysis for Better Investigations - A highly recommended QSR or GMP training course

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Monday, June 18, 2012

FDA Warning Letter Analysis: Supplement Manufacturers Cited for CGMP Violations, Lawncare

Warning Letter Analysis: Supplement Manufacturers Cited for CGMP Violations, Lawncare > RAPS > News - Article View:

"The US Food and Drug Administration (FDA) is continuing to crack down on dietary supplement manufacturers for alleged current good manufacturing practices (CGMP) violations, sending out two more warning letters to northeast supplement manufacturers NatureMost and Himalayan Institute of Buffalo. Among this batch of warning letters’ most prominent warnings: swapping ingredients without warning, violative marketing claims and a failure to cut the grass."

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Essentials for Pharmaceutical Manufacturers - a highly respected training course

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Friday, June 15, 2012

The Best Drug Companies Of The Past 15 Years

Over the last 15 years, according to Forbes, the pharmaceuticals industry has been undergoing somewhat of a drought when it comes to innovation and the creation of groundbreaking new products.

The Best Drug Companies Of The Past 15 Years - Forbes:

"What’s interesting is that the analysis bridges that long-term time period and the past decade, when much of the drug business has been in an innovation drought. And however you do it, the same names end up near the top: not only Novartis but also J&J and Merck. "

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Pharma IQ Reviews Innovation at the Top 10 Global Drug Companies Over the Last 15 Years by Pharma IQ

Wednesday, June 13, 2012

FDA releases nutritional guide to insects, vermin and pests

WARNING! The author of the article below states, "This article is, in fact, satire."

. . . you have to read this, it's hilarious!

FDA releases nutritional guide to insects, vermin and pests:

"That’s the message from the United States Food and Drug Administration (FDA), which today released a report on the nutritional value of more than 700 common insects, reptiles, rodents, amphibians and spiders.

The report, Let Them Eat Snake: The Nutritional Benefits of Insects, Vermin and Household Pests, hopes to “broaden American perspectives on food in the 21st Century.”"

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Reagan-Udall Foundation Receives FDA Funding to Advance Regulatory Science - MarketWatch

The Reagan-Udall Foundation for the Food and Drug Administration today announced it has received $900,000 from the FDA to support its FY2012 operations and infrastructure. The Foundation, an independent, non-profit organization, was created by Congress to advance the mission of the FDA through the study and pursuit of regulatory science initiatives.

Reagan-Udall Foundation Receives FDA Funding to Advance Regulatory Science - MarketWatch:

"Foundation priorities include exploring opportunities in the areas of food safety, novel approaches for developing therapies to fight tuberculosis, better understanding of cancer drug toxicities, and methods to enhance the FDA's ability to use clinical data sets for active post-market product safety surveillance. Additional areas of focus include scientific capacity building through training and fellowship programs for research scientists."

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Monday, June 11, 2012

P.R. China - Good Manufacturing Practice for Drugs (2010 Revision) - In English - Free

National emblem of the People's Republic of China
National emblem of the People's Republic of China (Photo credit: Wikipedia)
The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.

The document has 43 pages and is divided into 14 chapters with 313 paragraphs.

The link below takes you to the free English language version of the doucment.

State Food and Drug Administration, P.R.China (SFDA) - Ministry of Health (MOH) Decree No. 79 - Good Manufacturing Practice for Drugs (2010 Revision):

"Article 1: These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, are enacted to regulate the manufacturing and quality management of Drugs."

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Saturday, June 9, 2012

FDA delays decision on drug to prevent HIV

The FDA is delaying a decision on whether to approve a drug for preventing infection with HIV, for 3 more months.

FDA delays decision on drug to prevent HIV - The Washington Post:

"In May, a committee of FDA advisers recommended that the agency approve Truvada for HIV prevention in specific high-risk groups, including men who have sex with men and partners of those infected with HIV.

After that meeting, the FDA asked Gilead to revise its risk-management plan for the drug, Miller said.

She declined to provide details on how Gilead revised this plan, which is known as a risk evaluation and management strategy."

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If approved, Truvada would become the first drug marketed for prevention of HIV. The FDA will now make a decision by Sept. 14.

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New Wave of Cancer Combo Drugs Coming With Fewer Side Effects

New Wave of Cancer Combo Drugs Coming With Fewer Side Effects:

"A new wave of more-accurately targeted and less-toxic cancer fighting drugs that involve armed antibodies is on the horizon now, based upon a presentation made last weekend at the American Society of Clinical Oncology.

Side effects should be lessened and lives prolonged by this latest class of cancer drugs, which should translate well for patients with mesothelioma, the aggressive cancer caused by an exposure to asbestos."

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Friday, June 8, 2012

FDA Form 483 Can Form Basis of Class Action Lawsuit

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the US Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs.

Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report.

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:

"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."

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What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.

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Surviving an FDA Inspection - Recommended QSR & GMP Training by SkillsPlus International Inc.

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Wednesday, June 6, 2012

How Human Factors Lead to Medical Device Adverse Events

A nicely written article on "Human Factors."

How Human Factors Lead to Medical Device Adverse Events « QD Syringe Systems™:

"The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device."

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The Human Factors Program at FDA

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Monday, June 4, 2012

Top 10 Ways to Make GMP Training Relevant

A nice article with good suggestions and challenges to implement.

Blogs | Chem.Info | Top 10 Ways to Make GMP Training Relevant:

"There is nothing that could be more exciting and fulfilling than being part of a dynamic training group that equips its organization to be a finely tuned work force of scholars that embrace GMPs as a business enabler.

Unfortunately, rather than a graduate education in the pharmaceutics of regulations, our best and brightest are subjected to a mind-dulling deck of tired old PowerPoint slides.

Frankly, the problem is endemic and here's why:" . . .

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Sunday, June 3, 2012

The FDA should have the power to go after counterfeit drugs

The FDA is responding with plans to globalize its own operations by working out mutual inspection pacts with other nations and inspecting imports based on the likelihood that a particular drug has been tampered with.

The FDA should have the power to go after counterfeit drugs - Sentinel Source.com: Guest:

"In some countries, 30 percent to 50 percent of medications are counterfeit — unlicensed knockoffs or imitations of real drugs. A new study published in the June 2012 edition of the Lancet found that about a third of the anti-malaria drugs administered in Southeast Asia and sub- Saharan Africa were either counterfeit or so poorly made that they were ineffective.

In the United States, the problem of counterfeit drugs is still relatively rare, but growing. In February, a counterfeit version of the cancer drug Avastin that contained none of the active ingredient was purchased online by various medical groups that were ignorant of the fakery."

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Saturday, June 2, 2012

FDA and ISMP working together help consumers prevent errors

FDA and ISMP working together help consumers prevent errors:

"by Michael R. Cohen, R.Ph.

The U.S. Food and Drug Administration (FDA) and the organization I work for, the nonprofit Institute for Safe Medication Practices (ISMP), have long shared a common goal of helping consumers prevent medication errors. Now, to reach as many consumers as possible, FDA’s Center for Drug Evaluation and Research (CDER) has formally strengthened its relationship with ISMP so the two agencies can work together to provide consumers with information on how to use medicines safely."

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For more information, you might be interested in:
FDA and ISMP Work to Prevent Medication Errors

Friday, June 1, 2012

5/29/12 - Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies

Learn more details about these companies, and why they received warning letters.

Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies - RAPS - News - Article View:

"The US Food and Drug Administration’s (FDA) newest batch of warning letters was released on 29 May 2012, and some familiar faces have come under further scrutiny.

Medical device manufacturer McNeil PPC, a subsidiary of Johnson & Johnson, was hit with a lengthy list of claims by FDA, which said the firm is manufacturing no fewer than ten adulterated products. Three of the company’s Pennsylvania facilities are currently the subject of an FDA consent decree after the facilities repeatedly experienced manufacturing deficiencies and “several extensive recalls.” The company’s recent warning letter is extensive enough to draw parallels to the deficiencies which lead to the consent decree.

Medical device manufacturers Advanced OrthoPro Incorporated and Lebanon Corporation Incorporated also received citations for Quality System Regulation (QSR) deficiencies, while tissue bank company Gramercy Fertility Services was found to have violated human cells, tissues and cellular and tissue-based product (HCT/P) regulations."

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