US FDA Regulations Archives - ProRelix Research https://prorelixresearch.com/category/us-fda-regulations/ Clinical Research Organisation - 9001:2015 ISO Certified Company Wed, 19 Mar 2025 07:21:10 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://prorelixresearch.com/wp-content/uploads/2017/08/favicon.png US FDA Regulations Archives - ProRelix Research https://prorelixresearch.com/category/us-fda-regulations/ 32 32 FDA Validation Rules for Submission Data: Avoid Costly Mistakes! https://prorelixresearch.com/fda-validation-rules-for-submission-data/ Wed, 19 Mar 2025 06:28:29 +0000 https://prorelixresearch.com/?p=10819 FDA Validation Rules for Submission Data are essential for regulatory compliance. Learn about FDA data submission requirements, validator rules, study data standardization plans, and Pinnacle 21 validation. Stay updated with […]

The post FDA Validation Rules for Submission Data: Avoid Costly Mistakes! appeared first on ProRelix Research.

]]> Clinical Trials and Human Subject Protection as per US FDA https://prorelixresearch.com/clinical-trials-and-human-subject-protection-as-per-us-fda/ Tue, 05 Nov 2024 10:21:25 +0000 https://prorelixresearch.com/?p=10466 Clinical trials are necessary in advancing medical research and health care options by allowing new treatments to be introduced in the market through safety and efficacy testing in humans. Successful […]

The post Clinical Trials and Human Subject Protection as per US FDA appeared first on ProRelix Research.

]]> Food and Dietary Supplements Clinical Trials Regulations in USA https://prorelixresearch.com/food-and-dietary-supplements-clinical-trials-regulations-in-usa/ Fri, 28 Jun 2024 06:48:40 +0000 https://prorelixresearch.com/?p=10349 In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […]

The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

]]> Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management https://prorelixresearch.com/clinical-data-standardization-in-clinical-trials-fda-compliance-in-clinical-data-management/ Thu, 28 Dec 2023 11:49:01 +0000 https://prorelixresearch.com/?p=9881 Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […]

The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

]]> FDA Pharmacovigilance Regulations Update https://prorelixresearch.com/fda-pharmacovigilance-regulations-update/ Mon, 27 Nov 2023 08:48:46 +0000 https://prorelixresearch.com/?p=9770 The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […]

The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

]]> US FDA Foreign Clinical Trial Data Requirements https://prorelixresearch.com/us-fda-foreign-clinical-trial-data-requirements/ Wed, 15 Nov 2023 07:08:33 +0000 https://prorelixresearch.com/?p=9730 The growing impetus for the conduct of clinical trials outside the United States for products and medical devices intended to be used in the US include multiple reasons such as […]

The post US FDA Foreign Clinical Trial Data Requirements appeared first on ProRelix Research.

]]> FDA’s Clinical Data Standard Requirements for Clinical Trials https://prorelixresearch.com/fdas-clinical-data-standard-requirements-for-clinical-trials/ Fri, 13 Oct 2023 05:56:19 +0000 https://prorelixresearch.com/?p=9663 Clinical trials are critical for the approval of new drugs and medical devices necessitating that data that is derived from them to make regulatory decisions is done so in a […]

The post FDA’s Clinical Data Standard Requirements for Clinical Trials appeared first on ProRelix Research.

]]> Software as a Medical Devices (SaMD) and US FDA Guidance for their Clinical Evaluation and Clinical … https://prorelixresearch.com/software-as-a-medical-devices-samd-and-us-fda-guidance-for-their-clinical-evaluation-and-clinical-trials/ Mon, 14 Aug 2023 06:59:25 +0000 https://prorelixresearch.com/?p=9493 Software as a Medical Device (SaMD) refers to a class of medical software intended to be used for medical purposes or that is designed to carry out medical functions without […]

The post Software as a Medical Devices (SaMD) and US FDA Guidance for their Clinical Evaluation and Clinical … appeared first on ProRelix Research.

]]> FDA Guidance on Advancement of Decentralized Clinical Trials https://prorelixresearch.com/fda-guidance-on-advancement-of-decentralized-clinical-trials/ Thu, 03 Aug 2023 11:45:00 +0000 https://prorelixresearch.com/?p=9483 Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […]

The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.

]]> US FDA Medical Device Applications https://prorelixresearch.com/us-fda-medical-device-applications/ Mon, 26 Jun 2023 09:45:01 +0000 https://prorelixresearch.com/?p=9392 As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […]

The post US FDA Medical Device Applications appeared first on ProRelix Research.

]]>