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Regulatory

Easing Requirements for Minimal Risk Clinical Trials

Blogs, Clinical Regulatory, Regulatory /

Expediting clinical trials that post minimal risk is important to advance healthcare & drug development. In particular, easing the requirements for informed consent regarding trial participants- for minimal risk clinical trials- can help expedite the entire clinical development process and ultimately accelerate the overall regulatory approval process. Earlier the US FDA’s regulations allowed for exceptions […]

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Standardizing Real World Data for Drug and Biological Product Submissions

Blogs, Regulatory /

Real world data (RWD) is proving to be an important source of information for applications such as New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), biologic license applications (BLAs) and Investigational New Drug (IND) applications. With RWD being submitted as relevant “study data”, certain agencies like the US FDA, require that the format should

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Streamlining Clinical Investigations for Medical Devices

Blogs, Clinical Regulatory, Medical Device, Regulatory /

Clinical investigations for medicinal devices are critical in order to advance healthcare and patient safety. Streamlining clinical investigations help accelerate the delivery of innovative solutions to patients, which ensures timely access to devices that would help diagnose and treat diseases. Simplifying regulatory processes, enhancing stakeholder engagement, and aligning with global practices fosters more rapid approvals.

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Third Party Review Program for Medical Devices

Blogs, Medical Device, Regulatory /

The onset of the pandemic highlighted many obstacles pertaining to medical devices used to detect and diagnose the virus, SARS-CoV-2. Many device manufacturers emerged with their concerns and requested for “Emergency-Use Authorization” (EUA) for their in vitro diagnostic medical devices used to help detect the virus. In response to this request, the US FDA provided

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The Use of Item Response Theory in Clinical Outcome Assessments

Blogs, Clinical Regulatory, Regulatory /

Clinical outcome assessments (COAs) are a critical component of clinical trials and regulatory submissions for regulatory agencies like the US FDA. The US FDA defines a COA as a “measure that describes or reflects how a patient feels, functions, or survives”; COAs provide important information to the US FDA on the effectiveness of therapies so

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Utilizing Real-World Evidence for Medical Devices

Blogs, Medical Device, Regulatory /

Recent years have witnessed a surge in clinical practice data generation outside of trials, driven by advanced signal detection technologies and expanded database capabilities. The integration of real-world data (RWD) with artificial intelligence (AI) tools is reshaping regulatory and medical decision-making. Various user-generated practice data types are stored in centralized databases, offering valuable longitudinal observations

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Online Eligibility Checker Tool for International Recognition Procedure

Blogs, Regulatory /

The International Recognition Procedure (IRP), initiated by the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexit, establishes an international recognition route for medicines with pre-existing approvals from Canada, Australia, the EU, Japan, Switzerland, and the US. Operating alongside existing national procedures, the IRP is a crucial pathway for introducing innovative medications to UK patients while

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UK MHRA: Navigating Nuances in Clinical Trial Applications

Blogs, Clinical Regulatory, Regulatory /

The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives approximability 1000 clinical trial authorization (CTA) applications a year. These are for investigational medicinal products of which >95% are approved. However, >50% still need additional information to be submitted in order to get approved. The majority of the requests for additional information, including “grounds for

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Fostering bilateral trade and harmonized efforts in medicine regulation

Blogs, Regulatory /

The importance of aligning pharmaceutical regulations in the development process has become increasingly evident particularly in the current era that has characterized by global interconnectedness. Indeed, the need for harmonizing frameworks that govern medicine regulation and subsequently supporting bilateral trade has increasingly become imperative. As various pharmaceutical markets go beyond borders, disparities in their respective

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