U.S. Department of Health and Human Services

U.S. Food and Drug Administration

What is a Botanical Drug?

A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.

  • A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof.

  • A botanical drug product may be available as (but not limited to) a solution (e.g., tea), powder, tablet, capsule, elixir, topical, or injection.

  • Botanical drug products often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug products.

  • A botanical drug's special features require consideration and adjustment during the FDA review process. CDER issued a Guidance for Industry- Botanical Drug Products (PDF - 437KB) to take into consideration these features and to facilitate development of new therapies from botanical sources. The Botanical Guidance applies to only botanical products intended to be developed and used as a botanical drug product.

 

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Here above anyone can read the Biocence product line cleared and approved for FDA Registration as a Botanical OTC human drug NDC# 59998 by going to the Government site.

What is antimicrobial resistance? 

QWhat is antimicrobial resistance

A: Antimicrobial resistance occurs when microorganisms such as bacteria, viruses, fungi and parasites change in ways that render the medications used to cure the infections they cause ineffectiveWhen the microorganisms become resistant to most antimicrobials they are often referred to as “superbugs”. This is a major concern because a resistant infection may kill, can spread to others, and imposes huge costs to individuals and society.

Antimicrobial resistance is the broader term for resistance in different types of microorganisms and encompasses resistance to antibacterial, antiviral, antiparasitic and antifungal drugs. 

Antimicrobial resistance (AMR) occurs naturally but is facilitated by the inappropriate use of medicines, for example using antibiotics for viral infections such as cold or flu, or sharing antibioticsLow-quality medicines, wrong prescriptions and poor infection prevention and control also encourage the development and spread of drug resistance. Lack of government commitment to address these issues, poor surveillance and a diminishing arsenal of tools to diagnose, treat and prevent also hinder the control of antimicrobial drug resistance.

Q: What is the difference between antibiotic and antimicrobial resistance

A: Antibiotic resistance occurs when bacteria change in response to the use of antibiotics used to treat bacterial infections (such as urinary tract infections, pneumonia, bloodstream infections) making them ineffective

Antimicrobial resistance is a broader termencompassing resistance to drugs that treat infections caused by other microbes as well, such as parasites (e.g. malaria or helminths), viruses (e.g. HIV) and fungi (e.g. Candida).