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Digital Health: FDA Regulation of Mobile Medical Apps

As mentioned above, Agency regulation is driven by the level of risk patients face if the app were not to function as intended. Mobile apps that require regulatory oversight … See more

Actived: 3 days ago

URL: https://premierconsulting.com/resources/blog/2019-digital-health-fda-regulation-of-mobile-medical-apps/

New FDA Forms for INDs, NDAs, and BLAs: What to Know Before …

WebAt the end of March 2023, the FDA released two new forms that replace previous versions: Form 1571: Investigational New Drug Application (IND) form. Form …

Category: Health Go Health

Exploring The Dynamic Landscape Of Digital Medicines And Digital

WebDigital health products are widely used for the prevention, diagnosis, treatment, and management of health and disease. The introduction of digital …

Category: Health Go Health

The Target Product Profile: Basics and Benefits

Web2 Benefits of using a TPP. 2.1 Increased R&D efficiency. 2.2 Improved regulatory outcomes. 2.3 De-risked commercial outcomes. 3 Key takeaway. Defined by …

Category: Health Go Health

Preclinical And Nonclinical Studies—What Is The Difference, And …

WebHave you ever wondered about the difference between preclinical and nonclinical studies?While those in scientific fields like pharmaceutical development are …

Category: Health Go Health

Artificial Intelligence (AI), Machine Learning (ML) and the FDA

WebThe use of artificial intelligence (AI) and machine learning (ML) in drug development has increased rapidly, affecting areas directly overseen by the FDA, such …

Category: Health Go Health

The FDA Modernization Act 2.0: The End Of IND-Enabling …

WebAlthough the changes implemented by the FDA Modernization Act 2.0 are focused on reducing animal testing, this new openness to applying alternative models …

Category: Health Go Health

FDA INTERACT Meetings: Early Interactions for Cell and Gene …

WebGene therapy involves modifying or introducing genes into a patient’s body with the goal of treating, preventing, or curing a disease, while cell therapy requires …

Category: Health Go Health

Advancing Patient Healthcare: Clarifying The 2019 Changes In …

WebIn 2019, only 1.2 percent of global clinical studies included India, even though the country is estimated to bear 20 percent of the global disease burden.

Category: Health Go Health

Premier Consulting: The Leader In Development & Regulatory …

WebWe are scientists, researchers, strategists, and innovators on a mission to help biotech innovators transform their life-changing ideas and breakthrough science into …

Category: Health Go Health

Do You Have a Combination Product, and Is It Drug-led or Device …

WebWith the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate …

Category: Health Go Health

Drug Development For An Aging Population Premier Consulting

WebEvidence suggests a decrease in functional limitations and disabilities for people 85 years and younger. (2) Yet, an increase in chronic conditions has important …

Category: Health Go Health

Emergency Use Authorizations: What Is An EUA, And Does Your …

WebIt was amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013. Simply put, an EUA enables the expedited …

Category: Health Go Health

A Vitamin Approved As A Drug(!): Forget What You Think You …

WebOn 2 October 2017, Ascor ® (ascorbic acid injection for intravenous use) was approved for short‑term (up to one week) treatment of scurvy in adult and pediatric patients age 5 …

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Product Selection: Which Product To Develop

WebProduct Selection is based on four quadrants each drug development program needs to be successful. The four quadrants include: Regulatory. Scientific. Medical. …

Category: Medical Go Health

Risk Evaluation and Mitigation Strategies (REMS) Basics

WebIn 2007, the Food and Drug Administration Amendments Act (FDAAA) and one of its provisions gave FDA the authority to require Risk Evaluation and Mitigation …

Category: Food Go Health

Effects on Exclusivity: The Biologics Price

WebOn March 23, 2010, the U.S. FDA enacted the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Patient Protection and Affordable Care …

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Transitioning To ECTD V4.0 Premier Consulting

WebWith eCTD v3.2.2, the structure of submissions is web-based and consists of multiple XML files. However, eCTD v4.0 introduces a data-driven format, reducing …

Category: Health Go Health

Nonclinical Development Strategy and Study Design

Web1 Nonclinical strategy and study design. 2 Selecting the right studies. 3 Prioritizing studies to de-risk your program. 4 Designing with GLP in mind. With drug …

Category: Health Go Health

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