🌍🌱 Earth Day 2026
Sustainability starts with everyday choices.
This year, Thera-Business is building a corporate sustainability plan to reduce our environmental footprint.
🌿 Small actions can lead to meaningful impact.
💬 What’s one change—big or small—you’ve made to be more sustainable?
#EarthDay
🤖🩺 New draft guidance from the International Medical Device Regulators Forum outlines best practices for AI-enabled medical devices, including risk management, transparency, and human oversight.
📖 Read the draft guidance and provide public comment here: www.imdrf.org/consultation...
🌐 EMA highlights the need to better translate regulatory science into practice.
Focus on:
✔️ Early engagement
✔️ Clear regulatory pathways
✔️ Visible, usable research outputs
Proactive strategy will be key.
Read more here: www.raps.org/resource/eur...
#RegulatoryScience #EMA
🧬 Human trials begin for partial cellular reprogramming to reverse ageing.
Promising—but safety, endpoints & long-term effects remain key regulatory questions.
Read more here: www.nature.com/articles/d41...
#ClinicalTrials #RegulatoryScience #Biotech
🔍 What does “radical transparency” at the FDA look like?
A new JAMA article from the Center for Science in the Public Interest @cspinet.org calls for greater access to regulatory data to improve trust and decision-making.
📖 Read more here: www.raps.org/resource/adv...
🩷 Today is the International Day of Pink 🌸
A day to stand-up against bullying and hate, and stand in solidarity with the 2SLGBTQIA+ community.
This year’s theme, ECHO, reminds us to listen to and amplify queer and trans voices.
Together, we can create more inclusive, supportive spaces.
🧠🤖 AI in healthcare is moving into real-world use.
The FDA has cleared an AI ultrasound tool that can estimate gestational age in minutes, helping expand access to care in low-resource settings.
This marks a shift toward impact-driven innovation.
🔎 Read more below.
✡️ Happy Passover to all who are celebrating.
This holiday marks a time of reflection, resilience, and freedom—often shared with family, friends, and community around the Seder table.
Wishing our colleagues, clients, and partners a meaningful and joyful holiday.
Chag Sameach!
🚀 In ‘Project Hail Mary’, the hero saves Earth using something powerful: science.
From astrophysics to molecular biology, the film celebrates curiosity, experiments, and problem-solving.
Good science fiction can inspire real scientists —and get published in Nature!
🔭 Read the article below.
Today is International Transgender Day of Visibility, a day to celebrate the accomplishments of trans & nonbinary people & raise awareness of the work still needed to ensure equality.
At Thera-Business, we are proud allies of trans rights. We support your right to be your authentic, incredible self!
🧬 The FDA released draft guidance supporting New Approach Methodologies as alternatives to animal testing in drug development. Tools like organoids, organs-on-chips, and in silico models could improve prediction of human drug responses.
🔎 Find the guidance and submit comments below.
The FDA has finalized guidance for weight-loss medical devices, outlining recommendations for clinical study design, non-clinical testing, and benefit-risk evaluation to support weight-loss claims. The guidance also addresses the use of sham controls and appropriate study endpoints.
Read more below
A recent JAMA Health Forum Viewpoint argues current medical device frameworks may not fully address how generative AI evolves in practice.
Experts propose overseeing clinical generative AI more like human clinicians—with training, supervision, and ongoing evaluation.
Read the article below.
The FDA launched the Adverse Event Monitoring System, a platform providing real-time access to adverse event reports across regulated products. The new system consolidates multiple legacy databases into a single dashboard & aims to improve transparency & strengthen post-market safety monitoring.
As #X4Summit wraps up, the Thera-Business team is grateful for the inspiring event.
We were honored to join Derrick McLean, PhD at Qualtrics to present on how synthetic data can expand research possibilities for hard-to-reach populations.
Thanks to the Qualtrics team and X4 community!
🌙✨ Eid Mubarak from @Thera-Business!
Wishing our colleagues, clients, and partners celebrating Eid al-Fitr a joyful day filled with peace, gratitude, and time with family and friends.
May the celebration bring happiness and blessings to you and your communities.
#EidMubarak #EidAlFitr
🍀 Happy St. Patrick’s Day from Thera-Business!
Whether you're enjoying the festivities, wearing green, or just hoping to find a bit of luck in your day, we wish you a happy and joyful St. Patrick’s Day. 🌈🪙
The FDA released draft guidance to streamline biosimilar development, potentially reducing certain clinical pharmacokinetic studies when scientifically justified. The move could cut development costs by up to 50% and expand access to more affordable biologic therapies. Read the draft guidance here:
🐟🔔 Have you rung the fish doorbell?
In Utrecht, ecologists set up a live underwater camera at a canal lock. When viewers spot migrating fish waiting, they ring the digital “de visdeurbel” or “fish doorbell” to alert operators to open the lock. Join the millions watching and help the fish pass!
🚀 Second approval under the FDA’s National Priority Voucher pilot.
Hernexeos for HER2-mutated lung cancer reached a decision 44 days after filing, highlighting the promise—and debate—around ultra-fast drug reviews.
Read more about the latest approval and the CNPV pilot program below.
🚀 RecovryAI wins FDA Breakthrough Device Designation for its AI virtual assistant supporting post-surgical recovery.
As outpatient surgeries rise, AI-driven remote monitoring may help reduce complications and readmissions.
Read more below.
#AIinHealthcare #DigitalHealth #SaMD #RegulatoryScience
🌍 Happy International Women’s Day!
Today we celebrate the achievements, leadership, and contributions of women across every field and community. We also recognize the ongoing work needed to advance equity, opportunity, and inclusion for women everywhere.
#InternationalWomensDay #IWD2026
The RAPS Global Regulatory Strategy Conference is underway.
Thera-Business CEO Dr. Red Thaddeus D. Miguel is there connecting with colleagues and discussing global regulatory strategy and market access.
Today he presents “Chasing an Easier Method for Specific PMPF: Can Surveys Play a Role?”
🌈 Happy Holi!
Today we celebrate the Festival of Colors, a vibrant tradition that marks the arrival of spring and symbolizes renewal, joy, unity, and the triumph of good over adversity.
At Thera-Business, we're wishing all who celebrate a joyful Holi filled with color, laughter, and connection.
The FDA has issued draft guidance introducing a new framework to support individualized therapies for rare diseases when RCTs aren’t feasible. The “Plausible Mechanism Framework” emphasizes mechanistic evidence and targeted treatment approaches.
Download the draft guidance and provide comment here:
Thera-Business CEO Dr. Red Thaddeus D. Miguel will present at the upcoming Qualtrics X4 Summit 2026, highlighting how the responsible use of synthetic data can expand healthcare research and open opportunities to study hard-to-reach populations.
Read more here: therabusiness.com/news.php
💗 Pink Shirt Day
Today, we stand together in support of kindness, inclusion, and respect.
At Thera-Business, we are committed to fostering a culture built on professionalism, collaboration, and zero tolerance for bullying or discrimination.
Let’s choose kindness. 💕
The FDA has approved Optune Pax, a novel device delivering tumor treating fields (TTFields) for locally advanced pancreatic cancer. The portable system supports at-home treatment and was approved via the PMA pathway based on clinical survival data.
Read the FDA Press Release below.
🌙✨Ramadan Mubarak! 🌙✨
Thera-Business wishes all those observing Ramadan, a blessed month.
Thera-Business is pleased to share that our CEO, Dr. Red Thaddeus D. Miguel will present at the RAPS Global Regulatory Strategy Conference on March 6, to share insights on using structured surveys and alternative data approaches to support post-market performance follow-up.
Read more below.