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Regulatory

Model-Integrated Evidence Program for Generic Drugs

Blogs, Regulatory / By

Timely patient access to affordable treatment options is the goal of healthcare and regulatory agencies worldwide. To support this, early and frequent communication between drug applicants and regulatory agencies is required to expedite generic drug development and approval. Streamlined communication allows a better and clearer understanding of regulatory expectations and facilitates a more efficient application …

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Searchable Databases for Bio-Equivalence Guidance

Blogs, Medical Writing, Regulatory / By

Product-specific bioequivalence guidelines are crucial to support the development of safe, efficacious, and high-quality generic products. They provide information to manufacturers on how they can demonstrate therapeutic equivalence of their products compared to the reference drugs. Adherence to these guidelines streamline the regulatory approval process while also ensuring confidence with respect to the interchangeability of …

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Increasing Harmonization for Complex Generics

Blogs, Regulatory / By

Regulatory agencies across the globe are increasing their efforts in advancing the development of complex generics to facilitate patient and/or consumer access to safe, efficacious, and high-quality generic medicines. The generic medicine industry is already associated with many challenges such as declining profit margins and pricing making it a less attractive industry for generic pharmaceutical …

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Regulatory Roadmap for Access to MedTech

Blogs, Medical Device, Regulatory / By

In an era driven by technological advancements, particularly in healthcare, the need to implement a robust regulatory framework is more than ever to ensure compliance and patient safety. Indeed technological disruptors such as implantable medical devices, artificial intelligence, software, and diagnostics play a crucial role in healthcare whether they facilitate early detection or prevent complex …

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Fostering Medical Innovation with Expedited Review Processes

Blogs, Regulatory / By

2023 marked a significant year in the pharmaceutical industry as the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) approved an impressive 55 novel drugs. These approvals, including new molecular entities (NMEs) and new therapeutic biologics, underscore the FDA’s commitment to advancing patient care with innovative therapies. Over …

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Easing Requirements for Minimal Risk Clinical Trials

Blogs, Clinical Regulatory, Regulatory / By

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 / By

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 / By

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 / By

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 / By

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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