Thera-Business
@therabusiness.bsky.social
Experts in regulatory services | 25+ years of experience in #evidence-based reports and #regulatory documents. #SystematicReview #MetaAnalysis #Surveys
Ottawa, Canada | https://therabusiness.com/
Ottawa, Canada | https://therabusiness.com/
The FDA launches the TEMPO pilot under the ACCESS Model, giving ~40 chronic-care devices enforcement discretion before clearance. Goal: real-world evidence to speed innovation in metabolic, musculoskeletal and behavioral health care.
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
December 18, 2025 at 7:48 PM
The FDA launches the TEMPO pilot under the ACCESS Model, giving ~40 chronic-care devices enforcement discretion before clearance. Goal: real-world evidence to speed innovation in metabolic, musculoskeletal and behavioral health care.
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
Wishing a joyful and meaningful Hanukkah to all who celebrate! May this Festival of Lights bring warmth, reflection, and peace to you and your loved ones. ✨
#Hanukkah #FestivalOfLights
#Hanukkah #FestivalOfLights
December 15, 2025 at 8:15 PM
Wishing a joyful and meaningful Hanukkah to all who celebrate! May this Festival of Lights bring warmth, reflection, and peace to you and your loved ones. ✨
#Hanukkah #FestivalOfLights
#Hanukkah #FestivalOfLights
The @fda.gov has released draft guidance on Quality Management System info for certain PMA submissions, ahead of the QMSR rule taking effect in Feb 2026. Comments are open until Jan 16, 2026.
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
December 11, 2025 at 7:58 PM
The @fda.gov has released draft guidance on Quality Management System info for certain PMA submissions, ahead of the QMSR rule taking effect in Feb 2026. Comments are open until Jan 16, 2026.
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
December 10th is #HumanRightsDay. Today, we are reminded that dignity, freedom, and justice are everyday essentials.
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
December 10, 2025 at 9:51 PM
December 10th is #HumanRightsDay. Today, we are reminded that dignity, freedom, and justice are everyday essentials.
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
Today, on the National Day of Remembrance and Action on Violence Against Women, we honour the 14 women killed at École Polytechnique in 1989. As part of the #16Days of Activism, we recommit to ending gender-based violence.
#December6 #EndGBV #WhiteRibbon
#December6 #EndGBV #WhiteRibbon
December 7, 2025 at 9:41 PM
Today, on the National Day of Remembrance and Action on Violence Against Women, we honour the 14 women killed at École Polytechnique in 1989. As part of the #16Days of Activism, we recommit to ending gender-based violence.
#December6 #EndGBV #WhiteRibbon
#December6 #EndGBV #WhiteRibbon
Fierce Pharma’s 2025 Fiercest Women in Life Sciences celebrates women leading innovation across pharma & biotech.
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
December 5, 2025 at 5:15 PM
Fierce Pharma’s 2025 Fiercest Women in Life Sciences celebrates women leading innovation across pharma & biotech.
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
The Top 5 CNN Heroes of 2025 have been announced — five everyday people doing extraordinary good. 💛
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
December 3, 2025 at 2:27 PM
The Top 5 CNN Heroes of 2025 have been announced — five everyday people doing extraordinary good. 💛
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
On this #GivingTuesday, we’re proud to support those advancing equity, access, and better health. Today, our team is taking time to recognize the organizations that inspire us and make a meaningful difference in the communities they serve. 💙
#GivingTuesday2025 #HealthEquity #Impact
#GivingTuesday2025 #HealthEquity #Impact
December 2, 2025 at 4:10 PM
On this #GivingTuesday, we’re proud to support those advancing equity, access, and better health. Today, our team is taking time to recognize the organizations that inspire us and make a meaningful difference in the communities they serve. 💙
#GivingTuesday2025 #HealthEquity #Impact
#GivingTuesday2025 #HealthEquity #Impact
Dec 1 is #WorldAIDSDay, a moment to honour lives lost, support those living with HIV, and call for action to end AIDS.
This year’s theme, Overcoming Disruption, Transforming the AIDS Response, highlights the need for global solidarity, sustained investment, and action.
#EndAIDS #HIVAwareness
This year’s theme, Overcoming Disruption, Transforming the AIDS Response, highlights the need for global solidarity, sustained investment, and action.
#EndAIDS #HIVAwareness
December 1, 2025 at 7:24 PM
Dec 1 is #WorldAIDSDay, a moment to honour lives lost, support those living with HIV, and call for action to end AIDS.
This year’s theme, Overcoming Disruption, Transforming the AIDS Response, highlights the need for global solidarity, sustained investment, and action.
#EndAIDS #HIVAwareness
This year’s theme, Overcoming Disruption, Transforming the AIDS Response, highlights the need for global solidarity, sustained investment, and action.
#EndAIDS #HIVAwareness
This season reminds us how fortunate we are to work with exceptional clients and talented colleagues who make everything we do possible.
Thank you for your partnership, your insights, and your collaboration.
We’re grateful for you today and every day.
Warm wishes for a joyful Thanksgiving!
Thank you for your partnership, your insights, and your collaboration.
We’re grateful for you today and every day.
Warm wishes for a joyful Thanksgiving!
November 28, 2025 at 1:54 AM
This season reminds us how fortunate we are to work with exceptional clients and talented colleagues who make everything we do possible.
Thank you for your partnership, your insights, and your collaboration.
We’re grateful for you today and every day.
Warm wishes for a joyful Thanksgiving!
Thank you for your partnership, your insights, and your collaboration.
We’re grateful for you today and every day.
Warm wishes for a joyful Thanksgiving!
Today is International Day for the Elimination of Violence against Women and the start of the 16 Days of Activism against Gender-Based Violence.
Visit www.unwomen.org/en/get-invol... to learn more about what work is being done to ensure digital safety, and how to get involved.
Visit www.unwomen.org/en/get-invol... to learn more about what work is being done to ensure digital safety, and how to get involved.
16 Days of Activism against Gender-Based Violence
Women and girls around the world are exposed to online violence and digital abuse every day. AI is powering new and more sophisticated forms of digital violence. The crisis of gender-based violence is...
www.unwomen.org
November 25, 2025 at 7:23 PM
Today is International Day for the Elimination of Violence against Women and the start of the 16 Days of Activism against Gender-Based Violence.
Visit www.unwomen.org/en/get-invol... to learn more about what work is being done to ensure digital safety, and how to get involved.
Visit www.unwomen.org/en/get-invol... to learn more about what work is being done to ensure digital safety, and how to get involved.
FDA leaders are proposing a “plausible mechanism” pathway to help bring bespoke gene therapies to patients with rare, life-threatening conditions when randomized trials aren’t feasible. If adopted, this could transform how individualized medicines reach the market. Read more below.
FDA leaders propose new ‘plausible mechanism’ pathway for bespoke medicines
Two of the US Food and Drug Administration@s (FDA) top regulators proposed a new approach for approving personalized medicines under a so-called @plausible mechanism@ pathway. The pathway would enable the agency to approve individualized gene therapies and other bespoke medicines in cases where randomized trials are not feasible, and the biological cause of the disease is known.
@
www.raps.org
November 24, 2025 at 5:49 PM
FDA leaders are proposing a “plausible mechanism” pathway to help bring bespoke gene therapies to patients with rare, life-threatening conditions when randomized trials aren’t feasible. If adopted, this could transform how individualized medicines reach the market. Read more below.
Today, on World Pancreatic Cancer Day, help raise awareness about the 6th leading cause of cancer death worldwide.
Early detection matters. Learn the symptoms: stomach or back pain, jaundice, weight loss. If they persist, talk to your doctor.
Join the global call to raise awareness this #WPCD💜
Early detection matters. Learn the symptoms: stomach or back pain, jaundice, weight loss. If they persist, talk to your doctor.
Join the global call to raise awareness this #WPCD💜
November 20, 2025 at 7:07 PM
Today, on World Pancreatic Cancer Day, help raise awareness about the 6th leading cause of cancer death worldwide.
Early detection matters. Learn the symptoms: stomach or back pain, jaundice, weight loss. If they persist, talk to your doctor.
Join the global call to raise awareness this #WPCD💜
Early detection matters. Learn the symptoms: stomach or back pain, jaundice, weight loss. If they persist, talk to your doctor.
Join the global call to raise awareness this #WPCD💜
Nature dives into the rise of wetware computing, human-cell organoids trained to process signals, recognize patterns, and even learn simple tasks. The field shows promise, but researchers warn against overclaiming and mischaracterizing these systems. Read the full article below.
The computers that run on human brain cells
Move over silicon: scientists want to use neurons to make powerful computers with minuscule energy needs.
doi.org
November 19, 2025 at 4:26 PM
Nature dives into the rise of wetware computing, human-cell organoids trained to process signals, recognize patterns, and even learn simple tasks. The field shows promise, but researchers warn against overclaiming and mischaracterizing these systems. Read the full article below.
A new Nature collection charts early brain development in unprecedented detail, tracking how stem cells generate diverse neurons and glia in humans and mice, and revealing surprising evolutionary conservation across species.
Read more below.
Read more below.
First-ever atlas of brain development shows how stem cells turn into neurons
A collection of studies that chart how mammalian brain cells grow and differentiate is a ‘very valuable’ tool for neuroscientists.
doi.org
November 17, 2025 at 6:08 PM
A new Nature collection charts early brain development in unprecedented detail, tracking how stem cells generate diverse neurons and glia in humans and mice, and revealing surprising evolutionary conservation across species.
Read more below.
Read more below.
Today is #WorldDiabetesDay, a reminder of the growing global burden of diabetes and the importance of prevention, research & access to care.
At Thera-Business, we’re proud to support work that strengthens evidence, advances equity, and informs better outcomes.
🔗 Learn more at worlddiabetesday.org
At Thera-Business, we’re proud to support work that strengthens evidence, advances equity, and informs better outcomes.
🔗 Learn more at worlddiabetesday.org
November 14, 2025 at 3:12 PM
Today is #WorldDiabetesDay, a reminder of the growing global burden of diabetes and the importance of prevention, research & access to care.
At Thera-Business, we’re proud to support work that strengthens evidence, advances equity, and informs better outcomes.
🔗 Learn more at worlddiabetesday.org
At Thera-Business, we’re proud to support work that strengthens evidence, advances equity, and informs better outcomes.
🔗 Learn more at worlddiabetesday.org
AI is transforming healthcare. The HMA/EMA @ema.europa.eu is hosting a multi-stakeholder workshop on Nov 20–21, to explore regulatory frameworks, real-world use cases, and the future of AI across the medicines lifecycle.
🔗 Learn more and register here: www.ema.europa.eu/en/events/hm...
🔗 Learn more and register here: www.ema.europa.eu/en/events/hm...
November 12, 2025 at 4:59 PM
AI is transforming healthcare. The HMA/EMA @ema.europa.eu is hosting a multi-stakeholder workshop on Nov 20–21, to explore regulatory frameworks, real-world use cases, and the future of AI across the medicines lifecycle.
🔗 Learn more and register here: www.ema.europa.eu/en/events/hm...
🔗 Learn more and register here: www.ema.europa.eu/en/events/hm...
It was a great week in Phoenix with the #AMWA2025 community. The Thera-Business team was proud to help advance discussions on regulatory writing, AI in evidence synthesis, and the future of medical communication.
We are inspired by the community and energized for what’s ahead.
We are inspired by the community and energized for what’s ahead.
November 11, 2025 at 8:18 PM
It was a great week in Phoenix with the #AMWA2025 community. The Thera-Business team was proud to help advance discussions on regulatory writing, AI in evidence synthesis, and the future of medical communication.
We are inspired by the community and energized for what’s ahead.
We are inspired by the community and energized for what’s ahead.
Today, we pause to honour those who have served and sacrificed in times of war, conflict, and peacekeeping.
On Remembrance Day, we reflect with gratitude. Lest we forget. 🕊️
#RemembranceDay #LestWeForget #HonorAndRemember
On Remembrance Day, we reflect with gratitude. Lest we forget. 🕊️
#RemembranceDay #LestWeForget #HonorAndRemember
November 11, 2025 at 3:22 PM
Today, we pause to honour those who have served and sacrificed in times of war, conflict, and peacekeeping.
On Remembrance Day, we reflect with gratitude. Lest we forget. 🕊️
#RemembranceDay #LestWeForget #HonorAndRemember
On Remembrance Day, we reflect with gratitude. Lest we forget. 🕊️
#RemembranceDay #LestWeForget #HonorAndRemember
A great start for the Thera-Business team at #AMWA2025. Insightful sessions, engaging discussions, and meaningful connections. Looking forward to the rest of the week!
Stop by our booth and say hello if you're here!
#MedicalWriting #RegulatoryWriting #HealthComms
Stop by our booth and say hello if you're here!
#MedicalWriting #RegulatoryWriting #HealthComms
November 7, 2025 at 2:17 PM
A great start for the Thera-Business team at #AMWA2025. Insightful sessions, engaging discussions, and meaningful connections. Looking forward to the rest of the week!
Stop by our booth and say hello if you're here!
#MedicalWriting #RegulatoryWriting #HealthComms
Stop by our booth and say hello if you're here!
#MedicalWriting #RegulatoryWriting #HealthComms
The FDA has published internal CDER filing checklists to improve transparency & reduce costly delays in drug application reviews, helping bring innovative treatments to patients faster. Find the checklists in the latest update of CDER’s MAPP 6025.4 Good Review Practices: www.fda.gov/media/87035/...
November 5, 2025 at 6:49 PM
The FDA has published internal CDER filing checklists to improve transparency & reduce costly delays in drug application reviews, helping bring innovative treatments to patients faster. Find the checklists in the latest update of CDER’s MAPP 6025.4 Good Review Practices: www.fda.gov/media/87035/...
Welcome to #Movember! A month to highlight men’s health: cancer screenings, mental well-being, and prevention. Let’s stand together, start the conversation, and support breakthrough research. 💙
Find information about men’s health and ways to support and join Movember here: ca.movember.com
Find information about men’s health and ways to support and join Movember here: ca.movember.com
November 3, 2025 at 7:02 PM
Welcome to #Movember! A month to highlight men’s health: cancer screenings, mental well-being, and prevention. Let’s stand together, start the conversation, and support breakthrough research. 💙
Find information about men’s health and ways to support and join Movember here: ca.movember.com
Find information about men’s health and ways to support and join Movember here: ca.movember.com
We’re excited to see that @jama.com has launched JAMA+ Women’s Health, a new hub for sex-specific evidence in every specialty, not just reproductive care.
More research. More visibility. Better care.
📚 Check it out: jamanetwork.com/channels/wom...
#JAMAPlus #WomensHealth #EvidenceBasedCare
More research. More visibility. Better care.
📚 Check it out: jamanetwork.com/channels/wom...
#JAMAPlus #WomensHealth #EvidenceBasedCare
Women's Health Research and Opinion Articles from JAMA Network
Explore the latest science and reviews on pregnancy, weight loss, postpartum depression, abortion, menopause, and other health concerns in women.
jamanetwork.com
October 30, 2025 at 5:43 PM
We’re excited to see that @jama.com has launched JAMA+ Women’s Health, a new hub for sex-specific evidence in every specialty, not just reproductive care.
More research. More visibility. Better care.
📚 Check it out: jamanetwork.com/channels/wom...
#JAMAPlus #WomensHealth #EvidenceBasedCare
More research. More visibility. Better care.
📚 Check it out: jamanetwork.com/channels/wom...
#JAMAPlus #WomensHealth #EvidenceBasedCare
The Thera-Business team is headed to #AMWA2025 next week in Phoenix!
We’re looking forward to connecting and sharing ideas.
Don’t miss our CEO, Dr. Red Miguel, leading a roundtable on AI in systematic reviews.
🗓️ November 5–8. Are you attending? Let’s connect!
🔗 site.pheedloop.com/event/AMWA20...
We’re looking forward to connecting and sharing ideas.
Don’t miss our CEO, Dr. Red Miguel, leading a roundtable on AI in systematic reviews.
🗓️ November 5–8. Are you attending? Let’s connect!
🔗 site.pheedloop.com/event/AMWA20...
October 29, 2025 at 7:49 PM
The Thera-Business team is headed to #AMWA2025 next week in Phoenix!
We’re looking forward to connecting and sharing ideas.
Don’t miss our CEO, Dr. Red Miguel, leading a roundtable on AI in systematic reviews.
🗓️ November 5–8. Are you attending? Let’s connect!
🔗 site.pheedloop.com/event/AMWA20...
We’re looking forward to connecting and sharing ideas.
Don’t miss our CEO, Dr. Red Miguel, leading a roundtable on AI in systematic reviews.
🗓️ November 5–8. Are you attending? Let’s connect!
🔗 site.pheedloop.com/event/AMWA20...
As the DIA Canada Annual Meeting concludes in Gatineau, Quebec, our team is energized by the ideas and connections made over the past two days. Hear from Rami Ali, Project Coordinator at Thera-Business, as he shares his reflections on the conference and what’s next.
October 28, 2025 at 7:45 PM
As the DIA Canada Annual Meeting concludes in Gatineau, Quebec, our team is energized by the ideas and connections made over the past two days. Hear from Rami Ali, Project Coordinator at Thera-Business, as he shares his reflections on the conference and what’s next.