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FDA – Postmarketing Safety Reporting for Combination Products

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This DRAFT guidance addresses how to comply with the final rule on postmarketing safety  reporting (PMSR) requirements for combination products that FDA issued on December 20,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,”...

New FDA Guidance on Informed Consent Waiver for Clinical Investigations Involving No More than Minimal Risk

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...

New FDA Draft Guidance – Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11

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The FDA  released a new draft guidance document on 21 June 2017.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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Link to Draft Guidance Document: Use of...

FDA Announces New Draft Guidances on Medical Product Communications (FDAMA 114)

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...

FDA-Related Issues Not to Miss in the New Cures Legislation

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...
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