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This DRAFT guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016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,”...
by chuck_ltd | 27 Jul, 2017 | 21 Century Cures Act, CHCUK News & Articles, Pragmatic Trials, Real Word Evidence
FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv...
by chuck_ltd | 8 Jul, 2017 | EHR, eletronic Signatures, GCP, News
The FDA released a new draft guidance document on 21 June 2017. Comments should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. >>>Link to Draft Guidance Document: Use of...
by chuck_ltd | 12 Feb, 2017 | 21 Century Cures Act, Consultation, FDAMA114, Uncategorized
18 January 2017 – the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications...
by chuck_ltd | 12 Jan, 2017 | CHCUK News & Articles, News
On Dec. 13, President Obama signed into law the 21st Century Cures Act (Cures). The goal was to “accelerate the discovery, development and delivery” of innovative products, including by adding and modifying various programs administered by the Food and Drug...
