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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3D-Printed Medical Devices Spark FDA Evaluation | LiveScience

3D-Printed Medical Devices Spark FDA Evaluation | LiveScience:

"The FDA currently treats 3D-printed devices the same way it treats conventionally made medical devices, an FDA spokeswoman said.

"We evaluate all devices, including any that utilize 3D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used," spokeswoman Susan Laine told LiveScience in an email. She added, "In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device." "

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FDA - Hurricane Safety Checklist

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Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "

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FDA issues first social media rules for drug companies

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again. 

The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."

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Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)

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Related articles

• Should Mobile Medical Apps Require FDA Approval? (drughealth.blogspot.com)

CDRH Learn Course List (Spanish)

CDRH Learn; CDRH Learn Course List (Spanish):   'via Blog this'

It's great to see the FDA continue to expand their free training offerings, especially these in Spanish

CDRH Learn Course List (Spanish)
Listed below are the courses CDRH currently offers in Spanish. Additional online courses are being developed.

Course List

1. Overview of Regulatory Requirements: Medical Devices [New! 9/2]
2. Quality System Regulation 21 CFR Part 820 Basic Introduction
3. Export Certificates for Medical Devices
4. Overview of the Premarket Notification Process - 510(k)
5. Bioresearch Monitoring (BIMO) [New! 7/25]
6. Medical Device Reporting

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New FDA Guidance - New Contrast Imaging Indication Considerations

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The FDA has just released this new guidance document, "Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (pdf)." 

To get quickly up to speed on the gist of the guidance, read this commentary posted on the FDA Law Blog, "FDA Issues Contrast Imaging Draft Guidance; Implements Umbrella Approach to Imaging Device Labeling." 

In a nutshell, here's what the guidance covers . . . The guidance describes a process that allows either the imaging drug or imaging device developers to seek approval of medical imaging contrast indications using an already marketed imaging drug or biological product, including radiopharmaceuticals. 

 1. Device developers should generally submit a marketing application to add a new indication for using an already approved imaging drug under the circumstances described in this guidance. 1a. The data to establish these indications in a device application should include information developed in accordance with FDA existing guidance on Developing Medical Imaging Drug and Biological Products. 1b. For most types of indications as described in this guidance, when submitted to request marketing under a device application, the submission should be a Premarket Application (PMA). 

 2. Drug or biological product application holders of the already marketed imaging drug or biological product should generally submit an efficacy or labeling supplement, as appropriate, to add labeling for the new indication initially developed under a device application. 

 3. Device application holders may continue their current practice to request approval or clearance of labeling revisions for any new indications that may be initially approved in a supplement to the NDA for the imaging drug. 

 4. FDA expects to establish an internal intercenter imaging process to review and evaluate indications to ensure consistency in the development and review of clinical trials to establish the contrast indications that may be in either the drug or device labeling. 

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FDA CDRH Online Courses (Free)

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Very exciting! Check out these free courses at the CDRH Learn site. Here's why you want to go there . . .
CDRH Learn is the FDA’s Center for Devices and Radiological Health (CDRH) Web page for industry education. CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products.

CDRH Learn offers training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues.
Expect more training modules to get released, and eventually associated post-tests.

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Health And Safety Tips - Before and After A Hurricane

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The FDA has this fantastic collection of free tips and resources if you're potentially affected by a hurricane, "Hurricanes: Health and Safety Before and After a Storm." They offer so many items that I can only skim the surface of what's on the site. Here's the best I can do, here's a listing of the general categories of information they provide . . .

1. Drugs
2. Biological products
3. Food safety
4. Animal health
5. Medical devices
6. And lots of other information sources

Be well, and stay out of harm's way.
 

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Top Picks - Health Self-Monitoring Kits (video)

If you should be monitoring your blood pressure, or your blood sugars, then you need to watch this. This CBS News video shouts out their top picks for blood pressure monitoring, and blood glucose monitoring, "The Top Self-Monitoring Kits." And the top picks are . . . Their Top Blood Pressure Monitoring Kit:

• Omron Elite 7300W Womens Avanced Blood Pressure Monitor

Their Top Blood Glucose Monitoring Kit:

• One Touch UltraMini Blood Glucose Monitoring System Kit - 1 Ea

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Job Opportunities in the GMP and Health Sector

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Updated March 4, 2022

As you can imagine, this 2008 posts just didn't age well.  Sorry.

You might also be interested in:

cGMP Jobs in the U.S. - LinkedIn

---  the original post follows below  ---

Pursue this list of jobs, and job hunting resources. Plan your career in the health, drug, and regulated industries (e.g., GMP, drug manufacturing) or look for your next job, consulting engagement, or opportunity amongst these job hunting links. Getting one of these jobs can put you in a place to influence, guide, and support ethical research and manufacturing of medical devices and drugs. 

• Bio Jobs - blog of biopharmaceutical jobs, tools, many topics
• Careers with i3global - the company of specialists
• cGMP Job Listings - by job-hunt.org
• Executive Recruitment Services - by Med Exec Intl. Jobs in clinical research, QA, medical affairs, regulatory affairs
• GMP Consultancy Opportunities from MasterControl
• GMP Job Listings - by CareerBuilder
• GMP Job Listings - by CareerJet
• GMP Job Listings - by Juju 
• GMP Job Listings - by MySpace
• GMP Job Listings - by SimplyHired
• GXP Job Listings - by GXP Recruiters
• i3 Pharma Resourcing - pharmaceutical personnel placement
• RegulatoryOpenings.com - Regulatory, QA, Clinical, and Medical Writing openings & jobs

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