Saturday, December 19, 2015

Reports Shine Light on Prevalence of Health Data Breaches - iHealthBeat

Read the full article: Reports Shine Light on Prevalence of Health Data Breaches - iHealthBeat:

"About 90% of health care organizations have experienced a data breach within the last two years, according to the report.

The report predicted that cybercriminals will most likely focus their attacks on large insurers and health systems. However, it noted that "smaller incidents caused by employee negligence will also continue to compromise millions of records each year.""

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Thursday, December 17, 2015

America's 'Third Wave' Of Asbestos Disease Upends Lives : Shots - Health News : NPR

Read the full article: America's 'Third Wave' Of Asbestos Disease Upends Lives : Shots - Health News : NPR:

"The fire-resistant mineral first had killed asbestos miners, millers and manufacturing workers. Then it had taken out insulators, shipbuilders and others who worked with asbestos products. Eventually, conference attendees agreed, it would be roused from its dormant state in pipes, ceiling tiles and automobile brakes and kill again."

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Tuesday, November 17, 2015

Multiple cups of coffee a day linked to lower risk of death - UPI.com

Read the full article: Multiple cups of coffee a day linked to lower risk of death - UPI.com:

"Unlike previous studies, however, researchers also considered smoking. When taking cigarettes out of the mix -- because many people who smoke also drink a lot of coffee -- the data showed that 1.1 to 3 cups per day led to an 8 percent drop in mortality and 3.1 to 5 cups per day had a 15 percent lower risk of death. Those drinking five or more cups were 12 percent less likely to die."

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Catalent stops production at French plant, brings in law enforcement after it twice detects tampering - FiercePharma

Read the full article: Catalent stops production at French plant, brings in law enforcement after it twice detects tampering - FiercePharma:

"U.S.-based Catalent ($CTLT) has halted production at a softgel capsule manufacturing facility in France at the request of regulators after several incidents in which it appears someone within the plant purposely mixed the wrong capsules into batches. The company said it is working with French law enforcement and regulators to find out what happened."

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Monday, November 16, 2015

In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI - Free Tips

Read the full article for free tips: In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"For many medical device companies, it's a scary idea that an FDA inspector could show up at your reception desk tomorrow—or even today. Device executives need to ensure that everyone, from their regulatory affairs team to their receptionist, know how to interact with FDA personnel."

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#free #tips

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Thursday, November 12, 2015

FDA approves 3-D printing for pills - 10 News

Read the full article:  FDA approves 3-D printing for pills -  10 News: Tampa Bay Sarasota:

"The FDA has given approval to a new kind of pill – the first medicine made with a 3-D printer.

The drug is an anti-epileptic drug called Spritam. It’s the same drug as the widely prescribed Levetiracetam or Keppra."

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Tuesday, November 10, 2015

There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App - FDA Law Blog

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)


Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

Read the full article: FDA Law Blog: There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App:

" . . allows users to search by Active Ingredient, Proprietary Name, Applicant Holder, Application Number, and Patent Number.  Search results are displayed with tabs showing listings in the Prescription Drug Product List, the Over-the-Counter Drug Product List, and the Discontinued Drug Product List sections of the Orange Book.  Each drug product listing links to the same patent and exclusivity information appearing in the paper and electronic versions of the Orange Book, and . . . "

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You might also be interested in:
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Friday, November 6, 2015

Injections given every 8 weeks suppress HIV just as well as daily pills, trial finds - ScienceAlert

Read the full article: Injections given every 8 weeks suppress HIV just as well as daily pills, trial finds - ScienceAlert:

"Formulated to be long-acting and injected together, these two drugs suppressed the virus at a comparable rate to a combination of similar-acting pills taken daily. Patients received one shot either every four weeks, or every eight weeks, and the virus suppression rates were basically the same, although patients with monthly injections complained more about pain at the injection site – the most common side effect of this treatment."

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Monday, November 2, 2015

Death Rates Rising for Middle-Aged White Americans, Study Finds - The New York Times

Read the full article: Death Rates Rising for Middle-Aged White Americans, Study Finds - The New York Times:

"With the pain and mental distress data, Dr. Deaton said, “we had the two halves of the story.” Increases in mortality rates in middle-aged whites rose in parallel with their increasing reports of pain, poor health, and distress, he explained. They provided a rationale for the increase in deaths from substance abuse and suicides."

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Thursday, October 29, 2015

FDA Shows Up, a Man Runs, and Questions Emerge on China's Drugs - Bloomberg Business

Read the full article: FDA Shows Up, a Man Runs, and Questions Emerge on China's Drugs - Bloomberg Business:

"When FDA inspectors showed up at a Chinese company that supplies key ingredients to two of the U.S.’s biggest drug companies, a curious thing happened.

After lunch, they walked into a quality control lab on the second floor, where they saw a worker pull what looked like a memory stick from a computer and put it in the pocket of his lab coat. The inspectors asked to see what he’d taken.

And then the man turned and ran."

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You might also be interested in:
Surviving an FDA Inspection - A GMP training course by SkillsPlus Intl Inc.

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Tuesday, October 27, 2015

Inspection Observations - FDA.gov

Go to this FDA webpage:  Inspections > Inspection Observations - FDA.gov:

"FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the menu links on this page. These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Turbo EIR is FDA's automated Form 483 reporting system. Turbo EIR is utilized to generate the FDA Form 483 when applicable cite modules exist. Not all FDA Form 483s are generated in TurboEIR as some 483s are manually prepared and not available in this format. Observations have been broken out by Product or Program Area on separate tabs of the spreadsheet. The Product and Program Areas include the following:

  • Biologics
  • Drugs
  • Devices
  • Human Tissue for Transplantation
  • Radiological Health
  • Parts 1240 and 1250"

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In fiscal year 2014, you'll notice that biologics and drugs areas were highly associated with some kind of sub-standard investigation.

You might also be interested in this workshop:


Root Cause Analysis for Better Investigations - a cGMP Training Workshop by SkillsPlus Intl Inc.

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Thursday, October 22, 2015

Accusations highlight special pharmacies - Business Insider

Read the full article: Accusations highlight special pharmacies - Business Insider:

"Whether you believe accounting fraud allegations levied against pharmaceutical-firm Valeant or not, one thing is certain.

The pain isn't over — not for Valeant, not for any company in the pharmaceutical industry.

That's because what's really at the heart of the accusations against Valeant is the use of a new, shadowy segment within the pharmaceutical industry: specialty pharmacies."

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Wednesday, October 21, 2015

Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business

Read the full article: Big Pharma's Darknet Drug Deal - An Ex-Detective Is Tracking Down Knock-Offs To Counter A Dangerous Trade -  Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business:

"For the $300 billion pharmaceutical industry, the rapid growth of such marketplaces is a serious threat to profits and reputations. For regular folks who turn to the darknet because they’re uninsured or their coverage won’t pay for expensive medications, the choice can be lethal. Counterfeit drugs bought online have been shown to include everything from gypsum and rat poison to heavy metals and household cleaners."

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Friday, October 16, 2015

Top Reasons In-Person GMP Training Can Be Best

Call SkillsPlus International Inc. for live on-site in-person cGMP training that's:

Flexible, & Interactive

  • You get to: pick the date, time, & location; adjust for shifts, or number of days that works best for your employees; select your facility, plant, training center, or other desired location. 
  • In-person training engages students. With the right instructor, on-site training: encourages interaction according to class size and level of training, ensures consistent messages, fosters team building, offers real-time help & support, and provides the important “human touch” (which is often missing in technology-based training). 
  • Group interaction enhances learning. Employees learn from one another as well as from the trainer. The group setting also teaches employees how to interact with one another in a professional, productive, cooperative way, which is something that other forms of training often don’t provide. 

 Customized For Your Needs

  • Your training needs are addressed. Training content & activities are adjusted, based on students’ prerequisite & current skill levels, and the organization’s specific needs, objectives, issues, and challenges. Tailoring the content ensures that training is unique & relevant. 
  • Confidential issues can be covered. Training on-site means you can candidly discuss your organization's unique challenges and opportunities. Sensitive company information can be shared by participants and used as concrete examples during interactive and workshop sessions in complete confidence. 

 A Great Value

  • You get live in-person expert instruction! The best on-site teachers are skilled facilitators and/or consultants. With the right instructor, you get the added advantage of getting expert advice right on the spot, and training that is engaging & fun.

 Take The Next Step

#FDA #QSR #cGMP #GMP #training #courses #classes

Some people use the following descriptors to talk about live training: onsite, on-site, live, in person, in-person, customized, train more people, live classroom, person to person, face to face, instructor led, instructor-led, synchronous, traditional, personalized,in-class, conventional, classroom-based, live class, interactive teaching, regular classes, classroom training, real classroom, ILT, and instructor led training. 

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Tuesday, October 13, 2015

Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation

Read the full article: Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation:

"Ancestry.com, the popular genealogy site, is talking to the FDA about using DNA to estimate disease risk for the company’s member base. CEO Tim Sullivan revealed the news in an interview with The Verge, effectively announcing his company’s intention to eventually offer straight-to-consumer genetic testing.

Ancestry is currently in the "very early stages of a conversation with the FDA," Sullivan told The Verge. "We think it's totally appropriate that the FDA has stepped in to pretty aggressively regulate direct-to-consumer genetic tests—and we're just starting from that perspective, and trying to work very closely with them," he continued."

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Tuesday, October 6, 2015

Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology

Read the full article: Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology:

"Michael Kopcha, a pharma industry veteran with 25 years of experience in formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management, has been named the permanent director of FDA’s Office of Pharmaceutical Quality (OPQ), according to a Sept. 25, 2015 announcement by Janet Woodcock, director, Center for Drug Evaluation and Research (CDER). Kopcha will join CDER in November pending ethics clearance.

FDA’s OPQ was launched in January 2015 to implement processes and policies to provide better alignment among review, inspection, and research functions."

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FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post

Read the full article: FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post:

"The agency ordered a trio of manufacturers to conduct real-world evaluations on how well health care workers are cleaning and disinfecting the devices and what more might be done to prevent the spread of life-threatening infections.

Known as duodenoscopes, the devices are used in hundreds of thousands of procedures each year in the United States to drain fluids from pancreatic and bile ducts blocked by cancer tumors, gallstones and other conditions. Doctors consider them a key tool in detecting and treating medical problems in a minimally invasive way."

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Friday, October 2, 2015

Massive, unexpected drug price increases are happening all the time - Quartz

Read the full article & view graphics: Massive, unexpected drug price increases are happening all the time - Quartz:

"Valeant is the biggest standout. The Canadian company, a favorite investment of hedge fund icon Bill Ackman, has pursued a strategy of buying out other companies and drugs, slashing R&D budgets, and dramatically increasing prices. Its average price increase so far this year is 66%. Behind it are Allergan, Maltlinckrodt, and Mylan."

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Thursday, October 1, 2015

Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business

Read the full article: Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business:

"“It’s not just for the U.S. FDA, also the China FDA is understaffed as well,” said Jonathan Chan, an analyst in Hong Kong with Decision Resources Group, citing the size of the industry and the large number of drug applications. “It’s quite overwhelming. With agencies being understaffed, quality control and standards will get compromised.”"

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Friday, September 18, 2015

Officials urge vaccination with arrival of flu season - CNBC

Read the full article: Officials urge vaccination with arrival of flu season - CNBC:

"Officials on Thursday urged—repeatedly—every person in the country over the age of 6 months to get vaccinated for the flu, noting that vaccines are the single best way to prevent getting sick from the bug and losing days of work and school."

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Wednesday, September 16, 2015

How To Get The Best Deal On Your Prescription Drugs : Shots - Health News : NPR

View the important tips: How To Get The Best Deal On Your Prescription Drugs : Shots - Health News : NPR:

"The unaffordability of drugs is a real issue, even for people with health insurance. So how here's how to save money on your prescription drugs, whether you're insured or not." . . .

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Tuesday, September 15, 2015

Most Tricycle Deaths Happen When Children Fall into Swimming Pools - Scientific American

Read the full article: Most Tricycle Deaths Happen When Children Fall into Swimming Pools - Scientific American:

"Most deaths involving tricycles occurred when children fell into swimming pools while riding unsupervised, the researchers also found, leading to an important take-home message for parents.

"The environment in which children ride their tricycles should be free of pathways leading to sources of water," said study researcher Sean Bandzar, a medical student at the Medical College of Georgia. "In addition, parents should supervise all children riding tricycles.""

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Monday, September 14, 2015

More kids getting drunk on hand sanitizer - CNN.com

Read the full article: More kids getting drunk on hand sanitizer - CNN.com:

"Since 2010, poison control center hotlines across the United States have seen a nearly 400% increase in calls related to children younger than 12 ingesting hand sanitizer, according to new analysis by the Georgia Poison Center.

"Kids are getting into these products more frequently, and unfortunately, there's a percentage of them going to the emergency room," said Dr. Gaylord Lopez, the center's director."

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Supplement-Maker Who Diluted Products With Other Powders Sentenced To 40 Months In Prison – Consumerist

Read the full article: Supplement-Maker Who Diluted Products With Other Powders Sentenced To 40 Months In Prison – Consumerist:

"When you buy a food product or a dietary supplement, you should be confident that the product’s ingredients are listed on the label, and that you’re getting what you paid for. Federal prosecutors say that one dietary supplement wholesaler in New Jersey spent four years selling products diluted with products like maltodextrin or rice flour, increasing profits but defrauding customers. The company’s owner now must forfeit $1 million in profits and has been sentenced to 40 months in prison and one year of supervised release."

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Thursday, August 6, 2015

Need a Guidance Document? We’ve Got You Covered | FDA Voice

Read the complete post:  Need a Guidance Document? We’ve Got You Covered | FDA Voice:

"FDA’s Web & Digital Media team and the Office of Information Management and Technology have created a dynamic search list on one site so you can go to just one page and find the guidance documents you need, no matter where they are on FDA.gov. This search tool is powerful and easy to use. Now you can go to just one search box to find what you need in moments, instead of the 10 different pages on FDA’s website where guidance documents are posted."

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The FDA Guidance Search Tool: Search for FDA Guidance Documents

#FDA #GMP #training #cGMP

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Friday, July 17, 2015

The F.D.A.’s Medical Device Problem - The New York Times

Read the full op-ed: The F.D.A.’s Medical Device Problem - The New York Times:

"The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions. Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the F.D.A. are needed to ensure that innovative medical devices lead to better health."

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#FDA #GMP #training #cGMP

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Thursday, July 16, 2015

Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business

Read the full article: Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business:

"FDA spokesman Chris Kelly called the meeting an introduction and a chance "for the agency to begin a discussion on how we might collaborate with Google on identifying adverse event data, using Google’s technologies and data.”"

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#FDA #GMP #training #cGMP

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Wednesday, July 15, 2015

SurgeonRatings.org website makes data on surgeon performance public - CBS News

Read the full news article: SurgeonRatings.org website makes data on surgeon performance public - CBS News:

"A non-profit group is making millions of records on surgeon performance available to the public.

The consumer advocacy group Consumers' Checkbook launched the website SurgeonRatings.org, which provides open access to detailed government records on patient outcomes after surgery. It says the site was created after a ten-year campaign to convince the government to release Medicare records to the public."

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#FDA #GMP #training #cGMP

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Friday, July 10, 2015

FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products - FDA Law Blog

Read the full article: FDA Law Blog: FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The final rule requires “all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the products in the United States.”"

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You might also be interested in:
Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

#FDA #GMP #training #cGMP

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Thursday, July 9, 2015

FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs - Consumer Updates

Read the full update: FDA Consumer Updates > FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs:

"FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)"

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Thursday, July 2, 2015

Who Offers GMP Training?

Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. Here's why you need to choose SkillsPlus Intl Inc.:

Expertise - We've been delighting clients for more than 20 years. Allan Dewes, President & master trainer, combines his regulatory knowledge and operations experience to meet your needs. He's personable, an active listener, and a trusted partner to 100s of satisfied domestic & international clients. He helps clients succeed.

Live GMP Training - Leadership and course participants rave about our onsite courses. These popular courses are considered interactive, engaging, relevant, and sometimes fun! Students want to be in our classes, instead of trying to find ways to avoid going to class.

SkillsPlus Intl Inc. can be your one-stop shop that:
  • meets your needs, 
  • wows students, and 
  • makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call Allan Dewes, President & master trainer, (415) 948-5220.

#FDA #GMP #training #cGMP #courses #classes

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Tuesday, June 30, 2015

Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com

Read the full article: Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com:

"The governor of California has signed a contentious bill to impose one of the strictest school vaccination laws in the country.

Democratic Gov. Jerry Brown says in a statement Tuesday that science clearly shows vaccines dramatically protect children against infectious diseases."

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Thursday, June 25, 2015

Scientists describe the gross reason why your eyes sometimes sting, turn red in swimming pools - The Washington Post

Read the full article: Scientists describe the gross reason why your eyes sometimes sting, turn red in swimming pools - The Washington Post:

"The CDC also said in its report that the chlorine smell of pools isn't actually what you think. "What you smell are actually chemicals that form when chlorine mixes with pee, poop, sweat and dirt from swimmer's bodies... These chemicals -- not chlorine -- can cause your eyes to get red and sting, make your nose run, and make you cough."

"Yuck!" the CDC concluded."

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Wednesday, June 24, 2015

Fidgeting May Benefit Children With A.D.H.D. - The New York Times

Read the full article: Fidgeting May Benefit Children With A.D.H.D. - The New York Times:

"“I know it’s difficult to accommodate hyperactivity,” Dr. Schweitzer said, but it may really help children whose fidgeting bodies seem to contribute to calmer, more focused brains."

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Tuesday, June 23, 2015

Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ

Read the full article: Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ:

"Records indicated the company supposedly used an oxygen analyzer to obtain test results. But the FDA inspector displayed a Sherlock Holmesian propensity for uncovering discrepancies. The inspector spotted cobwebs running from the portable oxygen analyzer to an adjacent wall, according to the letter. In other words, the analyzer had not been used for, well, a while."

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Q7 Q&As - Quality Guidelines : ICH

Q7 Q&As - Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Follow this link to the Q7 section: Q7 Q&As - Quality Guidelines : ICH:

"Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs."

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Tuesday, June 16, 2015

The FDA takes step to remove artificial trans fats in processed foods

Read the full release:  Press Announcements > The FDA takes step to remove artificial trans fats in processed foods - FDA.gov:

"Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products. "

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