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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FDA on Tattoos and Permanent Makeup

Updated November 18, 2024

The original link broke.

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FDA Webinar on Tattoos and Permanent Makeup (PDF):  'via Blog this'

The FDA hosted a webinar on tattoos and permanent makeup. Bhakti Petigara Harp, Ph.D., of the Office of Cosmetics and Colors, Division of Color Certification and Technology in FDA's Center for Food Safety and Applied Nutrition, provided an overview of the composition of tattoo and permanent makeup inks and the pigments used in them, as well as their regulatory status. Dr. Petigara Harp talked about problems that have occurred with the use of these inks, such as allergic reactions, infections, and scarring, and addressed FDA's response to these occurrences. She also discussed misrepresentation of these inks and pigments as "FDA approved." 

Background:
FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA traditionally has not exercised its regulatory authority over tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
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Additional Resources:
Tattoos & Permanent Makeup: Fact Sheet - FDA.gov

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Medical device software criticized as under-regulated - latimes.com

Image via WikipediaMedical device software criticized as under-regulated - latimes.com:  'via Blog this'

In a nutshell:

"Between 1983 and 1997, 1 in 4 medical devices used software. Today, the figure is more than half. Software problems are now the third-leading cause for recalls of medical devices."

Just when you thought technology might move us ahead.

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FDA Warning On Weight Loss Products

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Updated December 28, 2021

The links in the original post broke.

You might also be interested in:

Tainted Weight Loss Products - FDA.gov

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No doubt we'll have overeaten on Christmas, and we'll continue to do so through the holidays. Then in the new year, we'll all be tempted to lose some weight. We'll schedule workouts at the gym, go on diets, and start taking weight loss products. But stop and read before you take those weight loss products, warns the FDA, as reported in a recent American Society of Health-System Pharmacists (ASHP) daily news briefing. In general, the FDA "has listed more than 25 weight loss products to avoid, because they contain ingredients that are not labeled, and could cause serious health problems." Some of the ingredients illegally contain drugs that should be sold by prescription only. The news briefing suggests the following links for further reading . . . Are you planning to take weight loss pills? 

Bloomberg News - Illegal Weight Loss Pills May Cause Heart Attacks 

FDA News - FDA Warns Consumers About Tainted Weight Loss Pills 

AP News - FDA warns against some diet pills sold on the Web 

HealthDay - FDA Warns About Weight Loss Products 

Chicago Tribune - FDA warnings for 30 diet drugs 

WebMD - FDA Warns of Risky Weight Loss Pills 

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FDA Struggles To Keep Products From Foreign Sources Safe

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This is required reading for consumers, and for professionals working in the GXP regulated industries (obtaining supplies, food, drugs, etc. from foreign suppliers). Gardiner Harris, a correspondent in The New York Times’s Washington bureau, writes about the very dangers and risk that are lurking out there in this NY Times news article, "The Safety Gap." The article is extremely well written and is full of anecdotes, statistics, and critical analysis that will make you think twice about the food and drugs that all of us are personally using. Here's what made me cringe . . .

1. It worries me that contributors to the story wanted to remain anonymous. It seems to me that perhaps the problem is much bigger than folks are willing to admit.
2. I'm guessing that the contaminated heparin from China incident is probably just the tip of a massive iceberg.
3. No surprise, the FDA is underfunded, understaffed, and ill-equipped to deal with the pent-up demand for foreign plant inspections.
4. It appears there is a danger that foreign plants are less committed to quality standards, and in some cases demonstrate a lack of ethical behavior.
5. I could go on, but it's much The Safety Gapfor you to read the news article.

Let the buyers beware (that means us as consumers, and companies partnering with foreign plants). 

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The Health, Drug, Prescription, and GMP Supersite: FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants 

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Residual Solvent Coalition Formed - Gets FDA Attention On USP Chapter 467

Updated May 31, 2021

The original link broke.

You can read more about this topic here:

FDA Answers Key Residual-Solvent Testing Questions - PharmTech.com

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When the FDA published its recent guidance document on residual solvents in drug products, it resulted in confusion and generated many questions. This recent PharmTech Talk post does an excellent job of framing the difficult situation, "Residual Solvent Concerns Lead to Coalition." In a nutshell, here are some of the important points PharmTech Talk makes . . .

1. Industry has experienced a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467
2. There have been so many problems that some core industry groups formed the Coalition for Rational Implementation of USP General Chapter <467>
3. The coalition had four key areas of concern: 1) testing versus control, 2) identification of Class 3 solvents, 3) use of Class 1 solvents, and 4) need for immediate relief while awaiting revised guidance.

Stay tuned, as there's hope the FDA will respond within the next couple of weeks. 

Previous Posts: The Health, Drug, Prescription, and GMP Supersite: New FDA Guidance - Residual Solvents in Drug Products 

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FDA Creates New Web Page of Drug Safety Information

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs, "Postmarket Drug Safety Information for Patients and Providers." On this page you'll find many resources organized in the following categories . .

• Drug Labeling
• Risk Evaluation and Mitigation Strategies (REMS)
• Studies and Clinical Trials of Approved Products Required by FDA or Agreed to by the Application Holder
• Registries and Clinical Trials
• Memorandum of Agreement Between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
• Latest Safety Information
• Reporting Problems to the FDA
• Warnings and Recalls
• Regulations and Guidance Documents
• Information about FDA's Drug Safety Oversight Board (DSB)
• Using Medicines Safely
• Consumer Articles on Drug Safety
• General Health Information
• FDA's Response to the Institute of Medicine's 2006 Report

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What Do You Think Is The Biggest Problem For The FDA?

Vote if you'd like, or just see the results of this Reader's Digest poll. . .

1. View the poll results, "What do you think is the FDA’s biggest problem? (results)"
2. Place your vote for, "What do you think is the FDA’s biggest problem? (vote)"

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Is The FDA Sick?

Good question. There's a superb Reader's Digest article on just this subject, "Strong Medicine: What's Ailing the FDA? -Is America's consumer watchdog understaffed, overburdened, ethically challenged or merely misunderstood?" This is an easy read, and very well-written. The article is organized by the following problems and what's being done about them . . .

1. Pressure From the Industry
2. Safety of New Drugs
3. Sloppy Record Keeping
4. Conflicts of Interest
5. Muzzled Experts

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