Regulatory Archives - Page 12 of 17

Prescription-Drug-Use-Related Software

Blogs, Labeling, Regulatory / development

Introduction With the advancement in digital technology, the development of prescription drug use-related software has surged, offering innovative solutions to enhance patient care, monitor drug adherence, and improve healthcare outcomes. The U.S. Food and Drug Administration (FDA) recognized the need to address software outputs related to prescription drugs and combination products. Prescription drug-use-related software is associated […]

Prescription-Drug-Use-Related Software Read More »

Requesting Post-Warning Letter Meetings

Blogs, Regulatory / development

During an inspection, the US FDA may detect that the manufacturer has violated a significant number of regulations. These could be low-quality manufacturing processes, issues regarding product claims, and even incorrect directions for use. In this case, the FDA notifies the manufacturer of the same by way of a Warning Letter which, in addition to

Requesting Post-Warning Letter Meetings Read More »

UK MHRA International Recognition Procedure

Blogs, Regulatory / development

The UK MHRA’s Latest Update on the International Recognition Procedure Introduction The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has taken a significant step towards enhancing its regulatory processes. The reason behind this step is to facilitate medicine access by expediting their approval. The MHRA has recently released comprehensive guidance on

UK MHRA International Recognition Procedure Read More »

Packaging Requirements for the Safety of Children

Blogs, Regulatory / development

Saudi Food and Drug Authority’s Requirements on Child-Resistant Packaging for Medications Posing Substantial Toxicity Risk. Introduction: The Saudi Food and Drug Authority (SFDA) stands as an unwavering guardian of patient safety in the Kingdom of Saudi Arabia (KSA). Renowned for its commitment to stringent and meticulous regulatory practices within the GCC region, the SFDA has

Packaging Requirements for the Safety of Children Read More »

How to prepare for oral explanations with EMA

Blogs, Regulatory / development

A marketing authorisation application (MAA) can take up to 210 days in which EMA experts spend time to assess the information provided by the applicant which supports their MAA. This period can be interrupted by ‘clock-stops’ where EMA’s Committee for Medicinal Products for Human Use (CHMP) can raise questions that the applicant must address. Oral

How to prepare for oral explanations with EMA Read More »

Guidance on Informed Consent in Clinical Investigations

Blogs, Medical Writing, Regulatory / development

Within the realm of clinical research, the process of obtaining informed consent stands as a crucial cornerstone of ethical practice, serving to protect the rights and well-being of human participants. The U.S. Food and Drug Administration (FDA) recognizes the changing landscape of clinical investigations and the necessity to align with the 2018 Common Rule and

Guidance on Informed Consent in Clinical Investigations Read More »

US FDA: Enhancing the safety of cosmetic products

Blogs, Regulatory / development

In the ever-evolving landscape of personal care and aesthetics, cosmetic products have risen to prominence and have wielded significant influence over individual and societal perceptions of allure. Yet, the journey from development to commercialization is underpinned by a complex tapestry of regulations designed to ensure consumer safety, uphold product integrity, and govern industry practices. In

US FDA: Enhancing the safety of cosmetic products Read More »

Overcoming challenges in determining AI limits for NDSRIs

Blogs, Regulatory / development

Introduction Nitrosamine Drug Substance-Related Impurities (NDSRIs) share structural similarity with API and are therefore unique to every APIs. Drug products containing API that have 2° or 3° amines, when mixed with excipients that have the ability to cause the nitrosation reaction, are responsible for the formation of NDSRIs. There is often a lack of mutagenicity

Overcoming challenges in determining AI limits for NDSRIs Read More »

Mandating CADIFA for drug registration in Brazil

Blogs, Regulatory / development

Navigating through API requirements to successfully register a drug product can be challenging, especially when these requirements are embedded in drug product regulations. This was indeed the case for Brazil where rules and regulations for APIs were very much available but were unclear as they formed a part of the drug product regulations rather than

Mandating CADIFA for drug registration in Brazil Read More »

The Impact of Artificial Intelligence in the Lifecycle of Medicines

Blogs, Pharmacovigilance, Regulatory / development

The rapid digitalization of the biomedical and clinical research sectors has ushered in a new era of advancements, with artificial intelligence (AI) taking centre stage as a transformative solution. In particular, AI is revolutionizing drug discovery processes by harnessing the vast amount of data generated during molecule screening phases and preclinical studies. As a result,

The Impact of Artificial Intelligence in the Lifecycle of Medicines Read More »