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Regulatory Sciences
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Regulatory Sciences
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
Regulatory Sciences
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...
Quality & Compliance
In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. While the core principles of...
Quality & Compliance
Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with...
Medical Information
This fictional story illustrates how ProPharma can seamlessly support a REMS program to ensure patient safety, access to medication, and regulatory compliance. Through scenarios involving healthcare...
R&D Technology
Science and technology are evolving rapidly, with an explosion in machine learning (ML) and artificial intelligence (AI) creating new possibilities for scientific discovery, operational efficiencies,...
Quality & Compliance
Right now, you are sitting in front of your computer and wondering how, based on current project status, you will achieve your remaining project goals for the year or achieve those planned for the...
Medical Information
Current Landscape of Medication and Healthcare Access in India India's healthcare system is a complex landscape with significant disparities in access to medical services and medications. Despite...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...