Thursday, January 21, 2016

Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice

Read Dr. Ostroff's (FDA) full comments: Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice:

"We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families."

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Wednesday, January 20, 2016

Families Of Cancer Patients Prefer Less Aggressive End-Of-Life Care Focused On Comfort : LIFE : Tech Times

Read the full article: Families Of Cancer Patients Prefer Less Aggressive End-Of-Life Care Focused On Comfort : LIFE : Tech Times:

"Medical experts said that if a family and/or patient considers hospice care preferable to more aggressive hospital treatment, it should be communicated to doctors or caregivers as soon as possible.

"Don't wait for someone to suggest hospice," urges Dr. David Casarett, head of palliative care for Penn Medicine in Philadelphia. "By the time that a doctor thinks about hospice as an option, and suggests it, it's often too late."

A hospice or home hospice care may be better at providing pain or symptom management along with spiritual and emotional support, he says."

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Thursday, January 7, 2016

Popular GMP Training Courses

Here are some cGMP training ideas for the upcoming year.

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!













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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 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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