Thursday, December 18, 2014

Questionable Remedies for Eye Disease - NYTimes.com

RE: slowing the progression of macular degeneration and reducing the risk of vision loss

Read the full article: Questionable Remedies for Eye Disease - NYTimes.com:

"Some contained the right ingredients but not the right doses. Some added other stuff (selenium, B vitamins, grapeseed extract) that hasn’t been shown to slow macular degeneration and might actually reduce the effectiveness of the ingredients that do work. Of the 11 supplements that market research shows were top-sellers, only four duplicated the AREDS formula.

 Moreover, most manufacturers didn’t bother to point out that the AREDS results don’t pertain to everyone with macular degeneration, and that therefore some consumers won’t benefit from these products."

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Wednesday, December 17, 2014

Belly Fat Tied to Sudden Cardiac Death - NYTimes.com

Read the full article: Belly Fat Tied to Sudden Cardiac Death - NYTimes.com:

"As the researchers expected, those who died suddenly had higher rates of other cardiac risk factors, including obesity, hypertension, high cholesterol and more. But independent of these factors, those with the highest waist-to-hip ratio had more than double the risk of sudden cardiac death compared with those in the normal range. The increased risk was apparent only in nonsmokers."

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FDA Approves Blood Test That Gauges Heart Attack Risk – WebMD

Read the full article: FDA Approves Blood Test That Gauges Heart Attack Risk – WebMD:

"The U.S. Food and Drug Administration on Monday approved a new blood test that can help determine a person's future odds for heart attack and other heart troubles.

The test is designed for people with no history of heart disease, and it appears to be especially useful for women, and black women in particular, the agency said."

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Tuesday, December 9, 2014

Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT

Read the full article: Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT:

"The problem is “cultural,” said Shah, originally from India and now head of UK-based Sigma, speaking afterwards to in-Pharmatechnologist.com.

“The classic thing in India is these guys will never say no. You will say to them, ‘I need this done,’ and they’ll say ‘Of course.’”

The result is delays and frustration from buyers, he said."

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The Top 15 Medical Device Deficiencies Cited by FDA in 2014 | RAPS

Read the full article, and view graphics: The Top 15 Medical Device Deficiencies Cited by FDA in 2014 | RAPS:

"The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies.

Total 483s Issued Declines for First Time in Six Years"

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View FDA Inspection Data:
FY 2014 Inspectional Observation Summaries - Number of 483s Issued from the System (Inspections ending between 10/1/2013 12:00:00 AM and 9/30/2014 12:00:00 AM)

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Wednesday, November 19, 2014

CRN FDA GMP Warning Letter Database - For Dietary Supplements - Free

Read the full press release: CRN FDA GMP Warning Letter Database Document:

"The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today announced a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products tainted with illegal ingredients."

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Access the CRN FDA Warning Letters Database for Dietary Supplements

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Tuesday, November 18, 2014

FDA - Consumer Updates > Food Safety Tips for Healthy Holidays

Read the full article: Consumer Updates > Food Safety Tips for Healthy Holidays - FDA.gov:

"Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home.

"The good news is that practicing four basic food safety measures can help prevent foodborne illness," says Marjorie Davidson, a consumer educator at FDA."

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Additional links:

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Monday, November 17, 2014

Great American Smokeout - Thurs Nov 20 | American Cancer Society

Learn more:  Great American Smokeout | American Cancer Society:

"The American Cancer Society marks the Great American Smokeout on the third Thursday of November each year by encouraging smokers to use the date to make a plan to quit, or to plan in advance and quit smoking that day. By quitting — even for one day — smokers will be taking an important step towards a healthier life – one that can lead to reducing cancer risk."

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Friday, November 14, 2014

Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor

Read the full article: Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor:

"Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

Based on 15 years of experience and eight successful FDA inspections, here are some best practices to prepare for a successful FDA Inspection."

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Thursday, November 13, 2014

Hospital Workers Wash Hands Less at End of Shift, Study Finds - HealthDay

Read the full article: Hospital Workers Wash Hands Less at End of Shift, Study Finds - HealthDay:

"Health workers in hospitals wash their hands less often as they near the end of their shift, a new study has found.

And this lapse -- likely due to mental fatigue -- could contribute to hundreds of thousands of patient infections a year in the United States, the researchers noted."

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Tuesday, November 11, 2014

Trouble Swallowing Pills? Here’s 2 Ways to do it Right - American News

Read the full article for more details: Trouble Swallowing Pills? Here’s 2 Ways to do it Right - American News:

"“In conclusion, this study showed for the first time that two targeted techniques to facilitate tablet and capsule intake were remarkably effective and easy to adopt in the general population including patients with swallowing difficulties, and should therefore be generally recommended,” the study authors write."

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Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill - WSJ - WSJ

Read the full article: Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill - WSJ - WSJ:

"Doctors are testing seniors for drugs such as heroin, cocaine and “angel dust” at soaring rates, and Medicare is paying the bill.

It is a roundabout result of the war on pain-pill addiction.

Medical guidelines encourage doctors who treat pain to test their patients, to make sure they are neither abusing pills nor failing to take them, possibly to sell them.

Now, some pain doctors are making more from testing than from treating."

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Wednesday, November 5, 2014

GMP News: Statistical Analysis of FDA's Inspection Findings

Follow this link to view the graph: GMP News: Statistical Analysis of FDA's Inspection Findings:

"The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.

Another interesting summary is the webpage with FAQs relating to the 483 Form.

The following graph shows an analysis of the 483 identified during fiscal year 2013." . . .

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FDA: Consumer Updates > Mixing Medications and Dietary Supplements Can Endanger Your Health

Read the full article: FDA - Consumer Updates > Mixing Medications and Dietary Supplements Can Endanger Your Health:

"What is FDA’s Role?

Although FDA has oversight of the dietary supplement industry, it is the supplement manufacturers and distributors that are responsible for making sure their products are safe before they’re marketed. Manufacturers are required to produce dietary supplements that meet minimum quality standards, do not contain contaminants or impurities, and are accurately labeled.

FDA does not review supplements for effectiveness (as it does for prescription and OTC medications) before they enter the market. If the dietary supplement contains a new dietary ingredient, the manufacturer must submit for FDA’s review data on that ingredient’s safety—but not its effectiveness.

FDA takes enforcement actions against manufacturers if their products are found to be unsafe, adulterated and/or misbranded (for example, if their labeling is false or misleading) or if products marketed as dietary supplements are making claims to diagnose, mitigate, treat, cure, or prevent a disease."

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Friday, October 3, 2014

2014 Ebola Outbreak in West Africa - FDA.gov

Read the full FDA article: Medical Countermeasures Initiative > 2014 Ebola Outbreak in West Africa - FDA.gov:

"Fast Facts 
  • Ebola is the cause of a viral hemorrhagic fever disease.
  • Currently, there are no FDA-approved vaccines or drugs to prevent or treat Ebola.
  • Ebola does not pose a significant risk to the U.S. public.
Treatment:
CDC recommends supportive therapy for patients as the primary treatment for Ebola. This includes balancing the patient’s fluids and electrolytes, maintaining their oxygen status and blood pressure and treating them for any complicating infections."

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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