Human gene therapy represents a groundbreaking frontier in medicinal products for treating complex diseases. This therapy aims to transform gene expressions or modify cellular properties for therapeutic purposes. Regulatory agencies support this innovation by ensuring the required guidelines are in place. For example, the US FDA stands as a guiding beacon for sponsors that wish […]
CMC Considerations for Human Gene Therapy INDs Read More »
Biological products are derived from living organisms or cells encompass a wide array of essential medical interventions, including vaccines, gene therapy products, and blood derivatives. Thus, these products are relatively complex in nature which is why there is a need to maintain heightened vigilance and continuously monitor their safety and efficacy. It is crucial to
Commitment to Biological Product and Patient Safety in India Read More »
Advanced rare disease drug developers are companies or organizations that specialize in the research and development of treatments for rare diseases. Developing drugs for rare diseases poses unique challenges due to small patient populations, genetic variations, and the need for novel endpoint selection. In response, the FDA has allocated resources through initiatives like Prescription Drug
Empowering Rare Disease Drug Developers Read More »
The Association of Southeast Asian Nations (ASEAN) region presents an attractive opportunity for global pharmaceutical organizations that are looking to obtain market access in the respective ASEAN markets. This is due to its rapidly expanding healthcare market and harmonized regulatory processes. DDReg is thrilled to announce a significant stride in its commitment to supporting its
DDReg Opens Entity in Singapore Read More »
In the development of the UK’s medical device industry, a consortium of Approved Bodies (AB) united under the banner of the UK Association for Medical Device Approved Bodies, or simply, Team-AB. This coalition marks a landmark as these bodies converge to advocate for cohesive regulations in the evolving landscape of medical device oversight. The genesis
How is Team AB Gearing up for the new MedTech Legislation? Read More »
In the emerging boom of biopharmaceuticals, the remarkable advancements in cell and gene therapy (CGT) have ushered in a new era of medical possibilities. These groundbreaking treatments have the potential to revolutionize medicine, offering hope to patients with previously untreatable conditions. However, with innovation comes the need for strong regulatory frameworks to ensure safety, efficacy,
Harmonization for the Development of Cell and Gene Therapies Read More »
With the expansion of clinical research and development, precise labeling of investigational products is not merely a formality but a critical aspect ensuring the safety, efficacy, and regulatory compliance of clinical trials. Pharmaceutical companies are obliged to follow an integrated approach in labeling considering all aspects of clinical study planning to promote multilingual and multicultural
Essential Aspects of Labeling for Clinical Supplies and Investigational Products Read More »
Customer Requirement: An animal product company, based in Ireland, wanted to file an abbreviated new animal drug application (ANADA) with the United States Food and Drug administration (US FDA) for its non-steroidal anti-inflammatory drug (NSAID) product. The drug is used to relieve pain and inflammation that is associated with osteoarthritis & control post-operative pain in
Fulfilling stability data requirements for ANADA filings Read More »
The onset of the coronavirus, or COVID-19, created havoc across the globe since its emergence in December 2019 in Wuhan, China, and fast spreading potential. Though no longer considered a “public health emergency” (under section 319 of the Public Health Services Act), the virus and its new strains are still actively circulating. This requires rigorous
Assessing COVID-19 Symptoms in Clinical Trials Read More »
In the realm of healthcare, patients have a fundamental right to transparency and information regarding the procedures they undergo particularly with respect to medical devices used for surgical procedures. One often overlooks the aspect of this right which is the traceability labels for medical devices used in surgical procedures regardless of whether the device is
Asserting Patient Rights: The Importance of Labels for Medical Device Traceability Read More »
