The first of many likely new guidance documents on Laboratory Developed Tests (LDTs) is intended to help small entities understand the LDT final rule in plain language. 🔗 https://lnkd.in/gJp5gXAH #LDT #IVD #RegulatoryAffairs #MedicalDevices #FDA
MDC Associates, Inc.’s Post
More Relevant Posts
-
MDC can help you navigate this!
The first of many likely new guidance documents on Laboratory Developed Tests (LDTs) is intended to help small entities understand the LDT final rule in plain language. 🔗 https://lnkd.in/gJp5gXAH #LDT #IVD #RegulatoryAffairs #MedicalDevices #FDA
Laboratory Developed Tests: Small Entity Compliance Guide - Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
fda.gov
To view or add a comment, sign in
-
One for my Diagnostic network - I'm interested to hear thoughts on the FDA's plan to bring LDTs into its regulatory fold over the next 4 years? What impact is this going to have on the market? 👇 ✏ #FDA #IVD #diagnostics #LDTs #labdevelopedtests #IVDS
FDA issues long-awaited LDT final rule
raps.org
To view or add a comment, sign in
-
Associate Head of Practice (GCP US, GMP, CSV, GLP) | Quality Assurance Consulting | Client Relations/Governance | Lead Auditor Nonclinical/Clinical Laboratories
Newly updated regulatory information on the hottest topic to hit the laboratory world in quite a while. #regulatorycompliance #fda #ivd #ldt https://lnkd.in/eMQnmH2y
Laboratory Developed Tests
fda.gov
To view or add a comment, sign in
-
When a drug-device-combination product (DDC) is being developed for multiple markets, such as the US and EU, you must comply with the regulations set forth for these territories. This may be challenging as there are differences in requirements and deliverables. Learn more about the general concept of DDCs and intra-vaginal rings and the differences in some of the deliverables between the US and EU: 👇 https://bit.ly/3xxkgmb
Regulatory aspects to the development of intra-vaginal rings - Sever Pharma Solutions
https://www.severpharmasolutions.com
To view or add a comment, sign in
-
FDA issues guidance on translation of good laboratory practice study reports FDA recently issued a draft guidance for industry titled, “Translation of Good Laboratory Practice Study Reports: Questions and Answers,” including an accompanying guidance snapshot and recap podcast. The guidance provides information regarding the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations (21 CFR part 58) submitted to FDA for review. Studies conducted in compliance with GLP regulations are sometimes conducted by testing facilities located outside of the United States. This question-and-answer document is intended to clarify FDA’s recommendations concerning the translation of study reports from a non-English language into English for studies conducted in compliance with GLP regulations. #fdacompliance #fda https://lnkd.in/gvUhqeGa
Translation of Good Laboratory Practice Study Reports
fda.gov
To view or add a comment, sign in
-
Why should we complete the source validation registration of APIs in DGDA, Bangladesh? 40 second read!
API Source validation in Bangladesh
https://blog.pharmadra.net
To view or add a comment, sign in
-
Staci J Kearney, PhD, RAC and the team at Elevation Strategic Development, LLC has developed a #free informational presentation about #FDAs new proposed rule on #LDTs. Click the link below for your copy! #laboratorydevelopedtests #diagnostics #digitalpathology
Don't miss your chance to get Elevation Strategic Development, LLC's informational presentation that can help guide you through the vast scope and impact of #FDAs #LDT regulation. Click the link below to get access to your complimentary presentation. https://lnkd.in/gawG9znV #laboratory #digitalpathology #diagnostic #regulatory
ESD_LDT Presentation
22398241.hs-sites.com
To view or add a comment, sign in
-
Don't miss your chance to get Elevation Strategic Development, LLC's informational presentation that can help guide you through the vast scope and impact of #FDAs #LDT regulation. Click the link below to get access to your complimentary presentation. https://lnkd.in/gawG9znV #laboratory #digitalpathology #diagnostic #regulatory
ESD_LDT Presentation
22398241.hs-sites.com
To view or add a comment, sign in
-
Compliance Wednesday FDA’s Center for Biological Evaluation and Research has issued a Warning Letter to an Insitutional Review Board from an elite institution. The IRB failed to: 1. Ensure consent forms informed subjects of alternative treatment options. 2. Notification if compensation for clinical trial related injuries was available. 3. Confidential notification that FDA could review personal medical records related to the clinical trial. 4. Preparation of adequate meeting minutes. 5. Preparation and maintenance of IRB membership lists. This occurence of noncompliance is another example of how status of an institution is not a guarantee that regulations and recognized good practices are followed. #fda #cber #bimo #gcp #warningletter #irb #consent #compliance
Massachusetts Institute of Technology MIT - 663218 - 06/21/2024
fda.gov
To view or add a comment, sign in
-
Curious about how to transition a research IND to a commercial IND? Check out our latest blog post. https://lnkd.in/gKaEy6hm #regulatorycompliance #fdacompliance #ectd #submissions
From Research to Market: Navigating the Transition from Research IND to Commercial IND for FDA Submission
thesugarwateroperationsteam.com
To view or add a comment, sign in