Skip to content

Tag: Fda approval

Explore our comprehensive collection of health articles in this category.

What is BPC-157 called now? The status and alternatives explained

4 min read
Despite being widely marketed for healing, a recent FDA review classified BPC-157 as a 'Category 2' bulk substance, meaning it raises significant safety concerns and cannot be legally compounded for human use. This has led many to question what is BPC-157 called now and what its current legal status entails.

Understanding Who Qualifies for Stem Cell Treatment?

4 min read
According to the FDA, the only approved stem cell products are those containing blood-forming stem cells derived from umbilical cord blood for specific blood and immune disorders. Understanding **who qualifies for stem cell treatment?** is vital for making informed medical decisions and avoiding unproven therapies.

What is a medically accepted indication?

3 min read
Medically accepted indications play a critical role in drug coverage, with federal law defining them as uses approved by the FDA or supported by specific medical literature. Understanding what is a medically accepted indication is crucial for patients, providers, and insurers to navigate the complex landscape of prescription drug benefits.

What Are the Post Trial Procedures in Clinical Research?

5 min read
Over 54,000 clinical trials are currently recruiting participants in the U.S. alone, but what happens after those studies conclude? Understanding what are the post trial procedures is crucial for both participants and the public, as this final phase determines the study's impact and next steps for a potential treatment.

What Does Fast Track Get You in Modern Healthcare?

4 min read
Studies show that implementing fast-track pathways in emergency departments can significantly reduce patient wait times, sometimes by over 35%. So, what does fast track get you? This system offers patients faster, more efficient care by optimizing treatment flows for less critical conditions across different medical fields.

What does medically accepted indication mean?

4 min read
In the complex world of healthcare, a drug's approval for certain uses is a critical factor for insurance coverage. The Centers for Medicare & Medicaid Services (CMS) defines rules around this concept, making the meaning of **medically accepted indication** crucial for both patients and providers.

Understanding What is FDA Approved Laser Technology

4 min read
Did you know the term 'FDA approved' is often used incorrectly when discussing lasers? Understanding **what is FDA approved laser** technology requires knowing the specific regulatory pathways medical devices must follow, a crucial detail for patient safety and treatment efficacy.

Is class 4 laser FDA approved? Understanding Clearance vs. Approval

4 min read
While many assume a blanket 'approval' status, the reality is more nuanced. The FDA first cleared a Class 4 therapeutic laser in 2003, and since then, numerous devices have received clearance for specific indications, not a blanket approval. This crucial distinction impacts consumer safety and understanding of the technology.

Is Lemme Purr FDA Approved? A Deep Dive into Supplement Regulation

5 min read
A significant point of confusion for many consumers is the difference in regulation between prescription drugs and dietary supplements. When asking, "Is Lemme Purr FDA approved?", it is essential to understand that the U.S. Food and Drug Administration (FDA) does not pre-approve any dietary supplement, including Lemme Purr, for safety or efficacy.