FDA Releases Proposed Guidance On Combination Products

• People also ask about FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc.
  

Updated July 5, 2024:

Links broke in the original post.

You might also be interested in:
FDA - Combination Products Guidance Documents

- - -  original post follows below  - - -

This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice Requirements for Combination Products (pdf). According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

SkillsPlus Intl Info Blog

FDA Warns Of E-Cigarette Risk

Image via Wikipedia

The FDA Warns of Health Risks Posed by E-Cigarettes. Also known as "e-cigarettes," electronic cigarettes are battery-operated devices designed to look like and to be used in the same manner as conventional cigarettes. Sold online and in many shopping malls, the devices generally contain cartridges filled with nicotine, flavor, and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. “The FDA is concerned about the safety of these products and how they are marketed to the public,” says Margaret A. Hamburg, M.D., commissioner of food and drugs. In the FDA Consumer Update - FDA Warns of Health Risks Posed by E-Cigarettes (pdf), they state that they're concerned about:

• e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death
• the products may contain ingredients that are known to be toxic to humans
• because clinical studies about the safety and efficacy of these products for their intended use have not been submitted to FDA, consumers currently have no way of knowing: 1) whether e-cigarettes are safe for their intended use, or 2) about what types or concentrations of potentially harmful chemicals, or what dose of nicotine they are inhaling when they use these products

For folks in the regulated industries, you'll be interested to know that the FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act.

More FDA Information About E-Cigarettes

Previous Posts: Smoking Is Too Expensive - It is time to quit e-Cigarettes In The News (video) Fire Safe Cigarettes Are A Good Thing

Return Home: http://drughealth.blogspot.com/ 

FDA - FAQs About Combination Products

• FDA cGMP online training programs and courses taught by SkillsPlus International Inc.

If you're just getting into the regulations that govern combination products, or need a quick refresher, then check out this collection of FDA Frequently Asked Questions about combination products, published by the FDA. 

Return Home: http://drughealth.blogspot.com/ T

The FDA On Combination Products (drug-biologic with medical device)

• People are also interested in FDA GMP online training courses taught by SkillsPlus International Inc.

Updated June 30, 2021

The original link broke.

You can read more about the topic here:

Frequently Asked Questions About Combination Products - FDA.gov

---  the original post follows below  ---

It's hard enough to comply with a single set of regulations. Now it's even harder, if you manufacture a combination product (which has a drug/biologic component and a medical device component). That's because a larger set of rules and regulations have to be followed, says this PharmTech Talk article, "Combo Products Come with More Regs." 

Bottomline, you can expect an increase in "GMP regulatory action along both the laboratory and manufacturing lines." 

Previous Posts: 

Nice Review of US FDA Medical Device Regulation 

Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

FDA Guidance Documents - FDA Current Thinking (free) 

Return Home: http://drughealth.blogspot.com/ 

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Nice Review of US FDA Medical Device Regulation

This is an excellent introduction to, and review of the FDA's Medical Device Regulations. This report, "Review of U.S. Medical Device Regulation," published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA). The report tackles the subject in the following sub-topics . . .

1. Introduction
2. Regulatory Definition of Medical Devices
3. Risk-Based Device Classification
4. Safety and Effectiveness Requirements
5. Food and Drug Administration Programs/Regulatory Pathways
6. Quality Systems Regulation (QSR)
7. Regulation of Drug-Device Combinations (Combination Products)
8. Guidance Documents Available to the Device Industry
9. Conclusions

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store