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Key Differences and Market Impact: Generics vs. Biosimilars

Key Differences and Market Impact of Generics and Biosimilars

Blogs, Regulatory /

“Generics” and “biosimilars” are a distinct category of drugs that undergo different development pathways, are subjected to different regulatory requirements and market dynamics. Generic products are copies of small molecule products and are typically developed after the original, or reference product, small-molecule patent expires. Generic products must demonstrate bioequivalence to the reference product and are […]

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Project Orbis collaboration for global cancer treatment access and innovation.

Project Orbis: Transforming Global Cancer Treatment Access

Blogs, Clinical Regulatory, Regulatory /

Cancer continues to be a major cause of mortality around the world, highlighting the urgent need for innovative strategies to deliver life-saving treatments to patients. In this pursuit, U.S. Food and Drug Administration (FDA) launched an initiative called Project Orbis in 2019, to transform the global regulatory framework for oncology drugs. Project Orbis has showcased

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ISO IDMP Standards on Data Management for Medicinal Products

The Impact of ISO IDMP Standards on Data Management for Medicinal Products

Blogs, Regulatory /

The global standardization of information exchange regarding medicinal products is crucial to ensure consistent regulatory compliance, enhance patient safety, and facilitate seamless collaboration across global markets. The ISO IDMP standards help to achieve this by providing a robust framework to ensure identification of products, enhance interoperability between systems, and facilitate clear communication between all key

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Update FDA’s ICH M13A Bioequivalence Guidelines

Key Insights from FDA’s ICH M13A Bioequivalence Guidelines

Blogs, Clinical Regulatory, Regulatory /

Bioequivalence (BE) assessment is pivotal for determining the therapeutic equivalence of generic drug products to their respective reference-listed drugs (comparator products). The BE study should be conducted according to the guidelines set up by the U.S. Food and Drug Administration (FDA). One such guideline “M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms” is a set

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New Points Update of AREE in Latin America

Unlocking New Potential with the AREE Update in Latin America

Blogs, Regulatory /

In the rapidly evolving pharmaceutical landscape of the world, it is regulatory standards that ensure safe and effective drugs are delivered to patients. In Latin America, Brazil’s ANVISA has slowly been emerging as among the leading authorities of the region to help develop a more robust and globally harmonized framework. It stood out especially with

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Boost Efficiency and Compliance with EDRMS Solutions

Blogs, Regulatory /

The landscape of pharmaceutical regulatory affairs is developing at a rapid pace in multiple verticals to help enhance efficiency while ensuring strict compliance. This can be relatively daunting highlighting the need for robust systems and tools that can be integrated in daily work to improve operational efficiency. Electronic Document and Records Management Systems (EDRMS) solutions

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Role of AI in Literature Monitoring in Pharmacovigilance

Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance

Blogs, Medical Writing, Pharmacovigilance, Regulatory /

In the rapidly evolving landscape of pharmaceutical safety, integrating Artificial Intelligence (AI) into literature monitoring in pharmacovigilance processes has become necessary. It involves ongoing monitoring and assessment of adverse drug reactions (ADRs), and other potential risks associated with medicinal products. A critical aspect of PV is literature monitoring, which entails reviewing scientific literature, case reports, and

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A Guide to Using FDA’s eSTAR for Medical Device Submissions

Blogs, Medical Device, Regulatory /

The United States Food and Drug Administration (USFDA) introduced the electronic Submission Template and Resource (eSTAR) program as part of its efforts to modernize and streamline medical device submission. This initiative aims to streamline the 510(k)-submission pathway, which is essential for manufacturers seeking to bring new medical devices. As of Oct 1, 2023, the use

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ChatGPT Simplify Regulatory Affairs in Medical Devices

How LLMs like ChatGPT Can Simplify Regulatory Affairs for New Medical Devices

Blogs, Regulatory /

The European Union’s Medical Device Regulation (MDR) 2017/745 has significantly transformed the regulatory affairs landscape for medical device manufacturers by establishing strict requirements to ensure the safety and efficacy of devices before they reach the European market. These regulations demand detailed technical documentation, comprehensive clinical evaluations, and proactive post-market surveillance, creating substantial resource and time

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Barriers medical device adverse event reporting

Identifying Barriers in Reporting Medical Device Adverse Effects

Blogs, Pharmacovigilance, Regulatory /

Medical Devices are an important part of the healthcare delivery system used in the diagnosis, monitoring, and management of diseases. Recent scientific innovations and technological solutions have expanded the use of medical devices globally. Medical devices can include items such as apparatus, instruments, appliances, substances, in-vitro reagents, software, etc. and other related objects used for

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