The US FDA conducts drug manufacturing inspections for facilities to ensure they are compliant with the Current Good Manufacturing Practice (cGMP) standards. However, navigating through these inspections requires a clear and comprehensive understanding of several aspects. These include applicable manufacturing standards, site selection model, 483 forms, and how the FDA reviews the inspections and outcomes. …
DDReg took a significant stride toward nurturing its team’s potential by partnering with Oktane HR. Following the success of the ‘High Impact Manager Program’ held earlier, in June, DDReg & Oktane HR partnered once again to elevate the leadership and growth capabilities. This session was carefully curated for the next in-lines and was led by …
DDREG & OKTANE HR – Training and Development Program for Employees Read More »
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 …
Artificial Intelligence in Medicine Regulation– a perspective by Emer Cooke, Executive Director of the European Medicines Agency. Introduction Artificial Intelligence (AI) is revolutionizing the regulation of medicines by offering innovative solutions to enhance drug safety, efficacy, and overall patient well-being. With its ability to process vast amounts of data, identify patterns, and predict potential risks, …
Comprehending the Key Components of Formal Meetings for Biosimilar Development with the FDA Introduction The development and approval process for biosimilar or interchangeable biosimilar product development is a complex journey. It requires close collaboration between pharmaceutical companies and global regulatory consulting authorities. In the United States, the Food and Drug Administration (FDA) plays a pivotal …
Formal Meetings for Biosimilar Product Development with the US FDA Read More »
Navigating the Paediatric Investigation Plan and its Significance in the Development of Medicinal Products. The development and authorization of medicinal products for paediatric use are essential for ensuring the health and well-being of children. However, conducting clinical trials involving children requires a distinct set of considerations and ethical standards. To address these challenges, the concept …
Paediatric Investigation Plan in Medicinal Product Development Read More »
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 »
Introduction Regulatory agencies require sponsors to collect and provide data on the safety and efficacy of drugs that they have obtained from clinical trials. In addition to age, gender, and racial subgroups, these trials should also incorporate data on patient populations that are historically underrepresented in clinical research. Indeed, information from a diverse patient population …
Post-market safety data for underrepresented populations in clinical trials Read More »
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 …
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 »
