biologics Archives - EMMA International

The History of The Food and Drug Administration (FDA)

In 1906 the Pure Food and Drug Act (Dr. Wiley’s Law) was passed by the Congress and signed by President Theodore Roosevelt, bringing the governing body of the Food and Drug Administration (FDA) into existence. The first commissioner of the FDA was Dr. Harvey Washington Wiley, who previously was the chief chemist of the USDA Bureau of Chemistry [1]. Previously to the FDA, the Bureau of Chemistry regulated food safety. The implementation of the FDA was the first comprehensive consumer protection agency in the federal government [1]. The first glimpse into what would eventually become the FDA, was the U.S Pharmacopeia which was started back in 1820 and sought to standardize drugs [2].

Bringing a Medical Device to Market

The FDA divides Life science products up into different categories with their associated centers. These centers, for medical products, are Drugs, Devices, and Biologics. If a product applies to more than one of these centers, it is sent to the office of combination products which serves as the focal point for medical product classification and assignment issues.

Antimicrobial Resistance: An Overview

Evolution is the process of how a species changes over time in response to their environment. Often termed “Survival of the Fittest”, the topic was studied most famously by Charles Darwin. While it is present across all species, one of the biggest impacts it can make is the change in a microorganism’s genome to resist antimicrobial products. These are used to treat and cure infections and sterilize surfaces among others. For this reason, antimicrobial resistance (AMR) has become a global concern.

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Incorporating GDP through Lean Six Sigma

GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.

How does FDA regulate Complementary and Alternative Medicine

Ayurveda, which is a traditional system of medicine, originated more than 3000 years ago. This field of medicine pays larger emphasis on building strength of mind and body to cope with different kinds of stressors and infections.[i] There are studies which suggest that ayurveda can reduce pain, manage with symptoms of type 2 diabetes, etc.

FDA Warning Letters Are Public Information

For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity. It is an open disclosure of how poorly your organization complied with specific regulatory requirements.

Role Definition for Team Success

Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.

Regulation of MedTech Products in India

Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.