MDC Associates, Inc.’s Post

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

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

Why should we complete the source validation registration of APIs in DGDA, Bangladesh? 40 second read!

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

FDA issues guidance on translation of good laboratory practice study reports FDA recently issued a draft guidance for industry titled, “Translation of Good Laboratory Practice Study Reports: Questions and Answers,” including an accompanying guidance snapshot and recap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

One (01) Day left for Freyr’s webinar on ‘Navigating eCTD Submissions in China.’ Register now to gain Regulatory insights about China’s eCTD evolution. Register now. https://lnkd.in/dJSEKh4t   #China #eCTD #Freyr #Regulatory

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

To gain better insights into how Freyr successfully submitted ANDA correspondence to the US FDA under stringent timelines, read the proven case. https://lnkd.in/da8tAiAs #Publishing #Submissions #ANDA #CaseStudy #USFDA #FreyrSolutions

Last week I attended the FDA OSIS on-line workshop. Excellent and very relevant information for drug developers and CROs. This office conducts on-site inspections for study conduct and data reliability. There were five presentations by staff scientists  covering: -the OSIS mission (Office of Study Integrity and Surveillance).  -CREST (Collaboration, Risk Evaluation & Surveillance Team)  site selection methods and procedures. -Analytical Inspections (for bioavailability and bioequivalence studies). It included a list of common analytical issue findings. -Clincial site inspections. -GLP inspections. The summary included how the dreaded Form FDA 483 is processed. Most useful was the Q&A. The response to one key question: yes, OSIS does inspect facilities in the IND phase not just active clincial phases and approval submission phases. I have the slides, if interested.

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