by Syneos Health_1 | 10 May, 2019 | 21 Century Cures Act, Consultation, Cures Act, FDA Guidance, Real Word Evidence, Regulatory Grade RWE
This draft FDA guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA...
by Syneos Health_1 | 8 May, 2019 | Consultation, FDA Guidance, Rare Diseases, Real Word Evidence
The FDA has published a draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.” The purpose of this draft guidance (January 2019) is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in...
by Syneos Health_1 | 8 May, 2019 | Consultation, FDA Guidance, Rare Diseases, Registry
The Food and Drug Administration (FDA or Agency) has announced (27 March 2019) the availability of a draft guidance for industry entitled “Rare Diseases: Natural History Studies for Drug Development.” FDA is publishing this draft guidance to help inform the design and...
by Syneos Health_1 | 9 Dec, 2018 | 21 Century Cures Act, FDA Guidance, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Grade RWE
It’s here! The long awaited FDA “draft framework for implementation” of the real world evidence program required by Section 3022 of The 21st Century Cures Act (Cures Act) has been published. Framework for FDA’s Real World Evidence Program The Cures Act is...
by Syneos Health_1 | 9 Dec, 2018 | 21 Century Cures Act, Cures Act, FDA Guidance, Real Word Evidence
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them. Among other provisions, the Cures Act...
by chuck_ltd | 24 Mar, 2018 | CHCUK News & Articles, Digital Health Technology, FDA Guidance
This DRAFT guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,”...
