FDA Device History File vs. EU Medical Devices Directive Technical Files

The FDA has built the DHF around control. This is the defining factor. It has designed GMPs around this. For the FDA, the DHF shows design output as a product of design input. It traces the device’s development history, and how design requirements were met in accordance with 21CFR 820. FDA DHF shows design history […]

FOIA allows release of documents from the government

Description: This Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute What is FOIA? The Freedom of Information Act (FOIA) represents the implementation of freedom of information legislation in the United States.It was signed into law by President Lyndon B. Johnson on July 4, 1966 and […]

API is the biologically activesubstance in a drug

A pharmaceutical drug consists of the API and the excipient, the inert substance   Introduction: Active Pharmaceutical Ingredient An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that is biologically active. Some medications may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon which originally […]

Nutraceuticals are foods that provide medical or health benefits

Description: Since nutraceuticals are preventives, FDA is less stringent in enforcing regulations on nutraceuticals than on drugs What are Nutraceuticals?  Definition Nutraceuticals are defined as food or parts of food that provide medical or health benefits, including the prevention and treatment of disease.  The term ‘nutraceuticals’ combines nutrition and pharmaceutical. isolated nutrients, herbal products, and […]

DME’s help improve the quality of the patient’s life at home

Description: The patient must be incapable of performing routine activities without the DME  What is a DurableMedical Equipment? Introduction Any medical equipment used in the home in order to help in a better quality of living can be called as durable medical equipment (DME). This includes iron lungs, oxygen tents,power scooters, Nebulizers, catheters, hospital beds, […]