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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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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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 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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Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

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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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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.

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