Monday, July 21, 2014

Safety Alerts & Advisories > FDA Consumer Advice on Powdered Pure Caffeine

Read the full alert: FDA Consumer Advice on Powdered Pure Caffeine - FDA.gov:

"Key Message

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.

The FDA is aware of at least one death of a teenager who used these products.

These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.

Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.

Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages."

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Wednesday, July 16, 2014

GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 requires that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

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Monday, July 14, 2014

Spoonfuls can lead to medicine errors, study finds - US News

Read the full article: Spoonfuls can lead to medicine errors, study finds - US News:

"Parents who used spoonfuls "were 50% more likely to give their children incorrect doses than those who measured in more precise milliliter units," said Dr. Alan Mendelsohn, a co-author and associate professor at New York University's medical school.

Incorrect doses included giving too much and too little, which can both be dangerous, he said. Underdosing may not adequately treat an illness and can lead to medication-resistant infections, while overdoses may cause illness or side effects that can be life-threatening. The study doesn't include information on any ill effects from dosing mistakes."

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Wednesday, July 2, 2014

Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov

Read the full article: Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov:

"Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.

To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived."

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Friday, June 27, 2014

FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice

Read the full article (and view video): FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice:

"FDA regulators announced this evening that they approved for the U.S. market the 1st robotic exo-suit for helping patients with lower-body paralysis walk upright.

Called ReWalk , the motorized system is comprised of metal leg braces that strap around the legs and back, supplying movement to joints in the hips, knees and ankles. The system includes a watch-based remote that controls the suit's movements and patients rely on crutches to provide stability."

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Thursday, June 26, 2014

Aspirin May Cut Pancreatic Cancer Risk - NYTimes.com

Read the full article: Aspirin May Cut Pancreatic Cancer Risk - NYTimes.com:

"A new study adds to the evidence that low-dose aspirin, known to reduce the risk for heart disease, may also reduce the risk for pancreatic cancer.

Pancreatic cancer has a 93 percent fatality rate, and the National Cancer Institute estimates there will be about 46,000 new cases and 40,000 deaths from the disease this year."

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Wednesday, June 25, 2014

Dietary Supplement Manufacturer Audit Preparation - NPI

Read the full article: Dietary Supplement Manufacturer Audit Preparation - NPI:

"Common Mistakes Auditors Find

Recent GMP audits reveal companies failure to perform tasks in two main areas:

Quality Issues
  • Perform required identity testing on incoming dietary ingredients raw materials
  • Set appropriate specifications for raw materials, components and finished good product
  • Perform finished good product testing confirming identity, strength and composition
  • Lack of finished product release criteria (does finished batch conform to product spec?)
  • Adopt written procedures (e.g., SOPs)
  • Prepare and follow master manufacturing records (MMR) and/or batch production records (BPRs) for manufacture of dietary supplements (with formulation and batch size)
  • Document corrective actions undertaken
  • To conduct required material reviews and make disposition decisions
Facility Issues
  • Physical plant design
  • Sanitation requirements of the physical plant and associated grounds
  • Issues with manufacturing equipment and utensils"
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Electrical Current To Heal Cavities - Business Insider

Read the full article: Electrical Current To Heal Cavities - Business Insider:

"Researchers at King's College London have developed a technique called Electrically Accelerated and Enhanced Remineralzation, in which a device they've dubbed a "healing hand piece" is placed over the site of a cavity. The tool emits a small electrical current that promotes the remineralization of the tooth, driving calcium, phosphate, and other substances back into the enamel, the scientists told the Washington Post (cavities happen when bacteria break down, or demineralize, the enamel with acid). The technique would take about as much time and cost about the same or less than a traditional filling, and publications describing the technique should be published "in coming months," they said."

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Monday, June 23, 2014

Marijuana Considered for Looser Restrictions by U.S. FDA - Bloomberg

Read the full article: Marijuana Considered for Looser Restrictions by U.S. FDA - Bloomberg:

"U.S. regulators are studying whether restrictions on marijuana should be eased, a step toward decriminalizing the drug at the federal level.

The Food and Drug Administration is conducting an analysis at the Drug Enforcement Administration’s request on whether the U.S. should downgrade the classification of marijuana as a Schedule 1 drug, said Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA, at a congressional hearing."

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Sunday, June 22, 2014

Medtronic got hacked, company reveals | MassDevice

Read the full article: Medtronic got hacked, company reveals | MassDevice:

"Medtronic reported in regulatory filings today that it and 2 other unnamed "large medical device manufacturers" were targeted by hackers appearing to originate from Asia. Those infiltrators didn't breach any patient data, Medtronic assured regulators.

Medtronic offered few other details regarding the hack, but the disclosure seems to fall in line with an reports earlier this year that Chinese hackers targeted systems at Medtronic, Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ)."

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Tuesday, June 17, 2014

FDA Prepping Long-Awaited Plan to Reduce Salt - ABC News

Read the full article: FDA Prepping Long-Awaited Plan to Reduce Salt - ABC News:

"Food companies and restaurants could soon face government pressure to make their foods less salty — a long-awaited federal effort to try to prevent thousands of deaths each year from heart disease and stroke.

The Food and Drug Administration is preparing to issue voluntary guidelines asking the food industry to lower sodium levels, FDA Commissioner Margaret Hamburg told The Associated Press. Hamburg said in a recent interview that the sodium is "of huge interest and concern" and she hopes the guidelines will be issued "relatively soon."

"We believe we can make a big impact working with the industry to bring sodium levels down, because the current level of consumption really is higher than it should be for health," Hamburg said."

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Thursday, June 12, 2014

Put Medicines Up and Away For Child Safety

The FDA emphasizes that it's National Safety Month.

View the website of: Up and Away:

"Any kind of medicine or vitamin can cause harm if taken in the wrong way, even medicine you can buy without a prescription. Walk around your house and find a storage place too high for a child to reach or see."

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FDA > Fish: What Pregnant Women and Parents Should Know

Read the full article: Metals > Fish: What Pregnant Women and Parents Should Know - FDA:

"Key Message:  Eat 8 to 12 ounces of a variety of fish* each week from choices that are lower in mercury. The nutritional value of fish is important during growth and development before birth, in early infancy for breastfed infants, and in childhood."

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Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's     Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)     The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices     Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)     How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations     Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance     How to Develop and Manage Qualification Protocols for FDA Compliance         Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)     Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices     FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics     Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)     Clinical Studies Management: A Practical Guide to Success     Analytical Chemistry in a GMP Environment: A Practical Guide     Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)     Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook     Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)     Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)     Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition     Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)     Cleaning Validation: A Practical Approach     Validated Cleaning Technologies for Pharmaceutical Manufacturing     Risk-Based Compliance Handbook     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)     Bioprocess Validation: The Present and Future     Laboratory Validation: A Practitioner's Guide     Quality Assurance Workbook for Pharmaceutical Manufacturers     Risk-based Software Validation: Ten Easy Steps     ISO 13485 and FDA QSR Internal Audit Checklist     ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees     Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition     50 Creative Training Openers and Energizers     Personalized M&M Candies     Oriental Trading Co - Training toys and supplies     GMP Training Gifts & Giveaways     GMP Training & Quality Posters