Nicotinamide Mononucleotide (NMN) has been making waves in the world of dietary supplements. Touted as a potential fountain of youth and an elixir for longevity, NMN supplements have gained popularity among health enthusiasts. However, there's a catch: the Food and Drug Administration (FDA) has imposed restrictions on NMN dietary supplements, including FDA-approved food supplements. But why?
- October 31, 2023 Food and Food Supplements
- October 31, 2023 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
According to the World Health Organization (WHO), only 27% of lower-middle-income and low-income economies have national pharmacovigilance systems registered with the WHO program, compared with 96% of the high-income countries in the Organisation for Economic Co-operation and Development.
- October 30, 2023 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
In the realm of modern medicine, hope has taken on a new form - Advanced Therapy Medicinal Products (ATMPs). These groundbreaking therapies, utilizing genes, cells, and tissues, hold the potential to cure diseases that were once deemed incurable. Yet, within this potential lies a complexity that challenges the very core of pharmacovigilance.
- October 27, 2023 Regulatory Affairs, Regulatory Software & Services
In today's heavily regulated business environment, compliance with 21 CFR Part 11 is mandatory for companies within FDA-regulated industries utilizing electronic records and signatures, notably in the Life Sciences sector encompassing pharmaceuticals, biotechnology, CROs, and related fields. Non-compliance can lead to Regulatory repercussions, including warnings, fines, and other enforcement actions.
- October 27, 2023 Pharmaceuticals, Regulatory Medical Writing
Introduction
The rise of biopharmaceuticals has been nothing short of a revolution in the life sciences arena. These complex, large-molecule drugs have transformed the healthcare landscape, offering targeted and effective treatments for an array of diseases.
- October 27, 2023 Pharmaceuticals, Regulatory Medical Writing
Introduction
The landscape of drug discovery and development is experiencing a profound transformation, driven by the emergence of precision medicine. In this evolving paradigm, Quantitative Structure-Activity Relationship (QSAR) modeling emerges as a potent tool that has the potential to revolutionize the pharmaceutical industry.
- October 27, 2023 Pharmaceuticals, Regulatory Affairs
Introduction
The pharmaceutical industry is governed by a complex web of regulations designed to safeguard the integrity and safety of its products. At the core of this Regulatory tapestry lies the Federal Food, Drug, and Cosmetic (FD&C) Act, a foundational statute guiding the industry's operations. A key component of this Act is Section 582, commonly known as the Drug Supply Chain Security Act (DSCSA).
- October 25, 2023 Cosmetics Regulatory Services
Modernization of Cosmetics Regulation Act (MoCRA) is a new set of regulations that standardizes how cosmetic organizations conduct business and maintain the safety of cosmetic products they are using within a Regulatory framework. One of the key requirements of MoCRA is the labeling of cosmetic products.
- October 19, 2023 Pharmaceuticals, Regulatory Labeling
In the ever-evolving Regulatory compliance landscape, pharmaceutical companies face increasing challenges in ensuring that their product labels meet global standards. Global Label Management Technology (GLMT) is a powerful ally for this purpose. In this blog post, we will explore how pharmaceutical companies can leverage GLMT to streamline labeling processes and achieve compliance.
- October 19, 2023 Pharmaceuticals, Regulatory Labeling
In the pharmaceutical industry, ensuring patients have access to accurate and comprehensible information about their drugs is significant. The Core Patient Information Leaflet (Core PIL) is crucial in achieving this goal. It is a significant aspect of maintaining labeling compliance. In the following lines, we will provide an overview of what a core PIL is and the key elements involved in crafting a compliant one.