FDA MAP

Navigating the regulatory landscape with precision! 🌐✨ Proud to be the audit experts at FDAMap, ensuring compliance in over 100 successful audits for GCP, GLP, GMP, and GACP. Your FDA audit journey starts here – trust the map to success!

Learn more by visiting out website fdamap.com or email us at [email protected]

Dive into the future of biotech and clinical trials in 2024! 🌐🔬 Join our enlightening January webinars as we explore cutting-edge advancements, breakthroughs, and the next frontier of medical innovation. Don't miss out on the knowledge journey! 💻🚀
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Link to Registration: https://www.fdamap.com/webinars.html

Wishing you a spectacular New Year filled with joy, success, and exciting adventures! 🎉🥂 Happy New Year from all of us at FDAMap! 🌟

🚀 Breaking News: The proposed LDT Rule emerges as the most impactful event in the FDA regulatory landscape for 2023! 🏛️💡 Dive into the details of this game-changing development in our latest release
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Link to full article: https://www.fdamap.com/proposed-ldt-rule-is-the-biggest-impact-event-of-2023-in-fda-regulatory-space.html

Did you know? Aspirin is a time-tested remedy with a rich history! 🌐🌿

🌐✨ In 2023, ChatGPT takes center stage, revolutionizing healthcare and influencing FDA regulations! 🏥💬 Explore the transformative impact of AI in our latest release and its downfalls...
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Link to Full Article: https://www.fdamap.com/2023-the-year-of-chatgpt-its-effects-on-healthcare-and-fda-regulations.html

Wishing you joy, laughter, and all the festive cheer this holiday season! 🎄✨ Happy Holidays from the FDAMap team!

Jingling all the way with festive vibes at the FDAMap office! 🎄✨ Wishing you warmth, joy, and a sprinkle of holiday magic from our team to yours! 🎁🌟

Did you know? The roots of clinical trials trace back to 1747 when the first physician-conducted trial took place. 🕰️✨ From then to now, the journey of medical discovery continues! 🌐💉

Grateful for the opportunities, community, team, and clients that have supported us throughout the year. Wishing you all a Thanksgiving filled with love, laughter, and success. 🍁

We're excited to share our latest article on ChatGPT, a powerful AI tool that has been dubbed a 'Weapon of Mass Disinformation' in healthcare information. At FDAMap, we believe in the responsible use of technology to empower patients and improve healthcare outcomes. Join us in the conversation and let us know your thoughts.

🪔 Embracing the warmth of Diwali with joy and light! Happy Diwali from all of us at FDAMap. May this festival illuminate your life with happiness and success. ✨

Beginning Monday, September 25, 2023, anyone can turn to covidtests.gov to receive four free tests. Covid-19 hospitalizations have rapidly increased since July, with weekly admissions tripled prior to two months ago. Please take action and prepare, as we are nearing Holiday season!

When you're the guardian of personal data and acing your Privacy Act training like a boss! 🛡️🔒

Announcing a very successful Day 2 of our 5-Day Master Class in Virtual Trials Challenge with speaker this morning we discussed patient recruitment methods and campaigns, challenges, patient recruitment retention, and IRB approval of marketing materials. We are very excited to continue this challenge tomorrow for Day 3, where we will discuss data collection and management in virtual trials!

Use link: https://forms.gle/k6fwrTbpqfhyovxd8
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Need consulting services for your clinical trial? Complete the survey to receive a free 30 minute consultation and up to a 20% discount on our CRO services!

In a recent independent review, many
errors were reported about the start and completion
timelines for clinical trials reported on the
clinicaltrials.gov registry. Does the FDA and NIH have
any set mechanisms for policing inaccuracies for these
timelines? Read the complete story linked below!

https://www.fdamap.com/clinical-trials-gov-is-full-of-err
ors-about-study-timelines.html

For the full story, visit:
https://www.fdamap.com/fda-limits-extensions-on-crl-responses-for-anda.html
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So far, FDA liberally granted extensions for the CRL responses, but not for long. In a new guidance document describing a previously unenforced policy, FDA announced that it would limit the number and duration of extensions granted to CRL responses for ANDA applications.

Register Today!
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This one-day training is run by experts working in the clinical trial industry to provide a first-hand overview of the practical aspects of conducting a clinical trial. Practical tips for management of a clinical trial project will be provided using case studies from the presenter’s personal experience. If you are aspiring to be a clinical project manager, are sponsoring a clinical trial, supervise clinical trial operations, or would like to become a clinical site, this training is a must for you.

Join us!
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https://www.fdamap.com/registration_undiscounted_fda_gmp_workshop.html

This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early-stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.

Join seasoned professional, Dr. Mukesh Kumar, PhD RAC in a discussion about gaining FDA's support in your clinical development programs!
Register link is located in our LinkTree, or down below!

https://www.fdamap.com/how-to-win-fda-support-for-your-clinical-development-program.html

On April 20th, at 1PM-2PM, we are holding an online webinar to discuss the 5 steps to find the best sites for your clinical trial!
Register link can be found in the LinkTree in my bio or down below!

https://www.fdamap.com/five-steps-to-finding-the-best-sites-for-your-clinical-trial.html

Join seasoned FDA compliance Dr. Mukesh Kumar in a critical discussion about finding clinical trial sites, to ensure your study goes smoothly!

Discover what role diversity plays in a clinical trial, and what the FDA and Biomedical Industry are currently doing to ensure diversity!

Link to the newsletter HERE!
https://www.fdamap.com/fdamap-newsletter-april-14-2022.html

Subscribe for more content like this on our website: www.fdamap.com or follow our page for daily information on FDA activities!

It is important that we push our loved ones to maintain healthy lifestyles, so make sure to ask them how long ago their last check up was!

Dr. Mukesh Kumar, PhD, RAC, is holding an exciting workshop on March 10th-11th, where you will learn key practices in how to effectively write in the FDA regulation industry!

Join Us! Sign ups will be located in our linktree, or at the following web address: https://www.fdamap.com/writing-technical-documents-for-fda.html

We're excited to see you there!

Happy New Year Everyone! This is the perfect time to reflect on the past year and make some healthy changes! Swipe for some helpful tips to set realistic resolutions, that will allow for a happier, and heathier year. ⁣⁣⁣⁣⁣
#2021 #2022

We begin this year supporting a critical campaign, supporting all efforts to motivate the public to donate blood. Look within your community for American Red Cross clinics, to end the shortage, or check out our LinkTree for the Red Cross clinic finder! Together, we can end the blood shortage.

LINK IN BIO for the full blog posts! Each week, new, topical postings of FDA updates, news, and well researched opinion pieces from a seasoned professional in the medical product industry are posted! ⁣⁣⁣⁣⁣⁣
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