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.

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.

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.

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).

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.

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.

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.

Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new set of regulations that standardizes how cosmetic organizations conduct business and maintain the safety of cosmetic products within a Regulatory framework. In the draft regulation, the enforcement deadline for facility registration is December 29, 2023. There are two (02) different deadlines for new facilities and existing facilities.

The increased Regulatory consideration of RWE in NDA/BLA submissions represents a fundamental shift toward a more patient-centric, evidence-based approach to drug evaluation. This approach has the potential to expedite access to life-saving therapies, particularly for those facing rare diseases and unmet medical needs.

In the fast-evolving world of pharmaceuticals and Regulatory Affairs, the way companies submit their drug applications to health authorities is transforming. One of the key developments in this realm is the implementation of Electronic Common Technical Documents (eCTD) baseline submissions.