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Control of Nitrosamine Impurities in Human Drugs

Food

FDA is implementing Pharmaceutical Quality/ Manufacturing Standards/ Current Good Manufacturing FDA is implementing this guidance on pharmaceutical quality, manufacturing standards, and Current Good...

Control of Nitrosamine Impurities, list of Nitrosamine Impurities, Nitrosamine Impurities guidelines, Nitrosamine Impurities in Drugs, Nitrosamine Impurities in Human Drugs, Nitrosamine Impurity

Categorization and Registration Process for Devices in EUDAMED

Medical Device

Device Categorization Devices submitted for registration in EUDAMED fall under the following categories: Regulation Devices – These include medical devices and in vitro diagnostic (IVD) devices...

Categorization and Registration Process, Categorization of devices to be registered in EUDAMED, eudamed device registration, medical device labeling requirements, Registration Process for Regulation Devices

Guidance on Premarket Submission for Device Software Functions

Medical Device

This draft FDA guidance outlines the recommended documentation that should accompany premarket submissions containing device software functions. It applies to both software in a medical device (SiMD)...

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Guiding Principles for Good Machine Learning Practice

Standards

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) have jointly outlined ten guiding principles to support...

artificial intelligence and machine learning, fda artificial intelligence, Guiding Principles for Good Machine Learning, Machine Learning-enabled medical devices, Medical Devices

ICH Guideline E8 (R1) on General Considerations for Clinical Studies

Standards

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those...

Center for Drug Evaluation and Research, Clinical studies of medical interventions, ich e8 general considerations for clinical studies, ich e8 guidelines

Registration of Drug-device Combination Products

Standards

NMPA Notice on the Registration Requirements for Drug–Device Combination Products To strengthen the regulatory oversight and registration management of drug–device combination products, and in accordance...

combinationproduct, drug, medicaldevice, NMPA, registrationofdrug, registrationondevice

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Categorization and Registration Process for Devices in EUDAMED

Guidance on Premarket Submission for Device Software Functions

Guiding Principles for Good Machine Learning Practice

ICH Guideline E8 (R1) on General Considerations for Clinical Studies

Registration of Drug-device Combination Products

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