Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004
Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004: Article 57(2) of Regulation (EC) No 726/2004, as amended by later regulations, plays a crucial role in ensuring the European Medicines Agency (EMA) has a comprehensive overview of all authorized medicines within the European Union (EU) and […]
Electronic submission of medicinal product information by marketing-authorisation holders
Electronic submission of medicinal product information by marketing-authorisation holders In the dynamic landscape of pharmaceutical regulation, the European Union (EU) stands at the forefront of ensuring the safety and efficacy of medicinal products. One pivotal aspect of this regulatory framework is the submission of comprehensive product information by marketing-authorisation holders (MAHs). Traditionally, this process involved extensive paperwork, […]
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment guidance provides recommendations to sponsors regarding the development of drugs and biological products regulated by CDER and CBER for the adjuvant treatment of renal cell carcinoma. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of […]
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative […]
Policy for Device Software Functions and Mobile Medical Applications
Policy for Device Software Functions and Mobile Medical Applications guidance to communicate how the Agency intends to apply its regulatory oversight to certain software, including device software functions and mobile medical applications (MMAs) intended for use on mobile platforms or on general-purpose computing platforms. FDA intends to apply its regulatory oversight to those device software […]
Medical Device Data Systems Medical Image Storage Devices and Medical Image Communications Devices
Medical Device Data Systems Medical Image Storage Devices and Medical Image Communications Devices guidance to communicate how the Agency intends to apply its regulatory oversight to medical device data systems (MDDS), medical image storage devices, and medical image communication devices. FDA does not intend to enforce the requirements of the Federal Food Drug and Cosmetic […]
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
FDA and industry action on Premarket Approval Application (PMAs): Effect on FDA review Clock and Goals. The Medical Device User Fee Amendments of 2022 (MDUFA V) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after […]
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). It is intended to help small entity establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) better understand the […]
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial guidance is to provide recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using […]