"PMDA" の関連情報検索結果
Expediting Drug Development in Japan: A PMDA Perspective - Kohno - 2025 - Wiley

Expediting Drug Development in Japan: A PMDA Perspective - Kohno - 2025 Wiley
Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first...

Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first Regulatory Affairs Professionals Society | RAPS
Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement...

Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement System PR Newswire
PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in...

PMDA more open to use of clinical data from other nations - BioWorld MedTech

PMDA more open to use of clinical data from other nations BioWorld MedTech
New gene therapy and weekly birth control patch move forward at Viatris - Stock Titan

New gene therapy and weekly birth control patch move forward at Viatris Stock Titan
BioCardia Advances CardiAMP Cell Therapy for Heart Failure with PMDA Consultation Completion - Qu...

BioCardia Advances CardiAMP Cell Therapy for Heart Failure with PMDA Consultation Completion Quiver Quantitative
Symplicity Spyral renal denervation system gains Japanese PMDA approval - Vascular News

Symplicity Spyral renal denervation system gains Japanese PMDA approval Vascular News
VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001 - GlobeNewswire

VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001 GlobeNewswire
BioCardia completed third preliminary clinical consultation with Japan’s PMDA - TipRanks

BioCardia completed third preliminary clinical consultation with Japan’s PMDA TipRanks
Eisai seeks PMDA approval for subcutaneous Leqembi in Japan - Yahoo

Eisai seeks PMDA approval for subcutaneous Leqembi in Japan Yahoo
Nadofaragene firadenovec under regulatory review in Japan - Urology Times

Nadofaragene firadenovec under regulatory review in Japan Urology Times
Asia-Pacific Roundup: PMDA posts points to consider for psoriatic arthritis clinical trials - Reg...

Asia-Pacific Roundup: PMDA posts points to consider for psoriatic arthritis clinical trials Regulatory Affairs Professionals Society | RAPS
PMDA makes case for Japan as a haven for innovation - BioWorld MedTech

PMDA makes case for Japan as a haven for innovation BioWorld MedTech
BioCardia (NASDAQ: BCDA) allowed to advance to formal PMDA consultation on CardiAMP HFrEF - Stock...

BioCardia (NASDAQ: BCDA) allowed to advance to formal PMDA consultation on CardiAMP HFrEF Stock Titan
MedHub-AI Receives PMDA Approval in Japan for AutocathFFR® - PR Newswire

MedHub-AI Receives PMDA Approval in Japan for AutocathFFR® PR Newswire
Asia-Pacific Roundup: PMDA outlines initiatives to promote pediatric drug development in Japan - ...

Asia-Pacific Roundup: PMDA outlines initiatives to promote pediatric drug development in Japan Regulatory Affairs Professionals Society | RAPS
Asia-Pacific Roundup: Japan’s PMDA starts offering consultation services from new US office - Reg...

Asia-Pacific Roundup: Japan’s PMDA starts offering consultation services from new US office Regulatory Affairs Professionals Society | RAPS
Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market - Regulatory Aff...

Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market Regulatory Affairs Professionals Society | RAPS
Asia-Pacific Roundup: PMDA discusses changes to warning letters - Regulatory Affairs Professional...

Asia-Pacific Roundup: PMDA discusses changes to warning letters Regulatory Affairs Professionals Society | RAPS
Asia-Pacific Roundup: NMPA adopts policy to cut time between drug approval and market supply in C...

Asia-Pacific Roundup: NMPA adopts policy to cut time between drug approval and market supply in China Regulatory Affairs Professionals Society | RAPS
Legacy Healthcare Receives Positive Feedback from Japan's Health Authority (PMDA) on Regulatory P...

JLK secures Japan PMDA approval for brain MRI AI solution - koreabiomed.com

JLK secures Japan PMDA approval for brain MRI AI solution koreabiomed.com
Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceu...

ZBH Receives PMDA Approval in Japan for iTaperloc Complete and iG7 - Zacks Investment Research

ZBH Receives PMDA Approval in Japan for iTaperloc Complete and iG7 Zacks Investment Research
Biocardia cell therapy to enter PMDA clinical consultation - marketscreener.com

Biocardia cell therapy to enter PMDA clinical consultation marketscreener.com
Asia-Pacific Roundup: Japan’s PMDA shares thinking on showing clinical efficacy in chronic skin c...

Asia-Pacific Roundup: Japan’s PMDA shares thinking on showing clinical efficacy in chronic skin condition Regulatory Affairs Professionals Society | RAPS
Pyromellitic Dianhydride (PMDA) Market 2025 Highlights Latest - openPR.com

Pyromellitic Dianhydride (PMDA) Market 2025 Highlights Latest openPR.com
BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA ...

ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes - Evotec

ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes Evotec
Russia Approves Move To Withdraw From Landmark Plutonium Deal With US - NDTV

Russia Approves Move To Withdraw From Landmark Plutonium Deal With US NDTV
BioCardia holds positive preliminary consultation with Japan’s PMDA - Investing.com

BioCardia holds positive preliminary consultation with Japan’s PMDA Investing.com
BioCardia’s Positive Consultation with Japan’s PMDA - TipRanks

BioCardia’s Positive Consultation with Japan’s PMDA TipRanks
Eisai and Biogen Submit New Drug Application for Subcutaneous LEQEMBI® to Japan's PMDA - Quiver Q...

Eisai and Biogen Submit New Drug Application for Subcutaneous LEQEMBI® to Japan's PMDA Quiver Quantitative
Russia Moves to Formally Exit Landmark U.S. Plutonium Disposal Pact - The Moscow Times

Russia Moves to Formally Exit Landmark U.S. Plutonium Disposal Pact The Moscow Times
178 Patient Trial Data: BioCardia's Breakthrough Cell Therapy for Heart Failure Advances in Japan...

178 Patient Trial Data: BioCardia's Breakthrough Cell Therapy for Heart Failure Advances in Japan Stock Titan
WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical...

WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical products World Health Organization (WHO)
Korea, Japan ink medical device info sharing pact - BioWorld MedTech

Korea, Japan ink medical device info sharing pact BioWorld MedTech
BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation wit...

BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA The Manila Times
PMDA rejects MC’s 100 acres land offer to set up Edu City - Times of India

PMDA rejects MC’s 100 acres land offer to set up Edu City Times of India
Submitting clinical data to the FDA and PDMA: An efficient and compliant approach - BioSpectrum Asia

Submitting clinical data to the FDA and PDMA: An efficient and compliant approach BioSpectrum Asia
Plutonium Management and Disposition Agreement (PMDA), Aim, Latest News - Vajiram & Ravi

Plutonium Management and Disposition Agreement (PMDA), Aim, Latest News Vajiram & Ravi
New Horizon in Clinical Development Strategy in Japan Based on New Guideline on Japanese Phase 1 ...

PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impac...

PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage Wiley Online Library
PMDA demolishes illegal structure at Panchkula’s oldest shrine Nau Gaza Peer | Hindustan Times - ...

PMDA demolishes illegal structure at Panchkula’s oldest shrine Nau Gaza Peer | Hindustan Times Hindustan Times
Asia-Pacific Roundup: CDSCO seeks feedback how to ensure a level playing field for drug approvals...

Asia-Pacific Roundup: CDSCO seeks feedback how to ensure a level playing field for drug approvals Regulatory Affairs Professionals Society | RAPS
WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again - BioSpectrum Asia

WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again BioSpectrum Asia
Study notes disparities in new drugs approved in the US and Japan - Regulatory Affairs Profession...

Study notes disparities in new drugs approved in the US and Japan Regulatory Affairs Professionals Society | RAPS
Easing Market Entry: Japan’s PMDA Allows Approval Filings In English - Citeline News & Insights

Easing Market Entry: Japan’s PMDA Allows Approval Filings In English Citeline News & Insights
Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion - Regulator...

Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion Regulatory Affairs Professionals Society | RAPS
Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec - Business Wir...

Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec Business Wire India
Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand - Regulatory Affairs Pr...

Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand Regulatory Affairs Professionals Society | RAPS
The Complete Guide to Using AI in the Healthcare Industry in Japan in 2025 - nucamp.co

The Complete Guide to Using AI in the Healthcare Industry in Japan in 2025 nucamp.co
Jurisdiction row: Addl chief secy for better coordination - Times of India

Jurisdiction row: Addl chief secy for better coordination Times of India
Asia-Pacific Roundup: Japan’s PMDA seeks to curb medical accidents - Regulatory Affairs Professio...

Asia-Pacific Roundup: Japan’s PMDA seeks to curb medical accidents Regulatory Affairs Professionals Society | RAPS
JLK wins Japan’s approval for AI stroke diagnosis tool - koreabiomed.com

JLK wins Japan’s approval for AI stroke diagnosis tool koreabiomed.com
FDA, Japan's PMDA strengthen ties to accelerate regulation processes - Philippine News Agency

FDA, Japan's PMDA strengthen ties to accelerate regulation processes Philippine News Agency
Following PMDA action in Panchkula: Sector-3 shrine voluntarily removes illegal structure | Hindu...

Following PMDA action in Panchkula: Sector-3 shrine voluntarily removes illegal structure | Hindustan Times Hindustan Times
Japan PMDA opens second overseas office in Washington - BioWorld MedTech

Japan PMDA opens second overseas office in Washington BioWorld MedTech
PMDA CEO conducts surprise inspection to fast-track Panchkula’s beautification drive - The Statesman

PMDA CEO conducts surprise inspection to fast-track Panchkula’s beautification drive The Statesman
Where The FDA And EMA Stand On Digital Endpoints - Clinical Leader

Where The FDA And EMA Stand On Digital Endpoints Clinical Leader
BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Isch...

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval Diagnostic and Interventional Cardiology
Regulatory cooperation to improve global health - European Medicines Agency

Regulatory cooperation to improve global health European Medicines Agency
Aurion Biotech receives approval from Japan’s PMDA for New Drug Application - Ophthalmology Times

Aurion Biotech receives approval from Japan’s PMDA for New Drug Application Ophthalmology Times
Two decades of new drug approvals in Japan - Nature

PMDA, HSIIDC begin pothole repair work in Panchkula - Times of India

PMDA, HSIIDC begin pothole repair work in Panchkula Times of India
Asia-Pacific Roundup: Japan’s PMDA translates advice on using e-consent technologies in clinical ...

Asia-Pacific Roundup: Japan’s PMDA translates advice on using e-consent technologies in clinical trials Regulatory Affairs Professionals Society | RAPS
PMDA giving new momentum to urban development in Panchkula: CEO Pandurang - ET Infra

PMDA giving new momentum to urban development in Panchkula: CEO Pandurang ET Infra
BioCardia, Inc. Completes Consultation with Japan's PMDA on BCDA-01 for Ischemic Heart Failure Tr...

BioCardia, Inc. Completes Consultation with Japan's PMDA on BCDA-01 for Ischemic Heart Failure Treatment Quiver Quantitative
Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections - Regulatory Aff...

Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections Regulatory Affairs Professionals Society | RAPS
Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline - Regulatory Affairs ...

Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline Regulatory Affairs Professionals Society | RAPS
Terumo Aortic announces PMDA approval for RelayPro endovascular device in Japan - Vascular News

Terumo Aortic announces PMDA approval for RelayPro endovascular device in Japan Vascular News
Panchkula road damaged in 2 months: DC directs PMDA, HSVP to conduct inspection, submit report - ...

Panchkula road damaged in 2 months: DC directs PMDA, HSVP to conduct inspection, submit report Times of India
PMDA CEO K. Makarand Pandurang conducts surprise inspection of Panchkula city - The Impressive Times

PMDA CEO K. Makarand Pandurang conducts surprise inspection of Panchkula city The Impressive Times
Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystem...

Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystems drugdiscoverytrends.com
Op-ed: PMDA advances regulatory science-based “rational medicine” - Foreign Policy

Op-ed: PMDA advances regulatory science-based “rational medicine” Foreign Policy
Terumo Aortic announces PMDA approval for Thoraflex Hybrid in Japan - Vascular News

Terumo Aortic announces PMDA approval for Thoraflex Hybrid in Japan Vascular News
Belite Bio completes submission to PMDA to initiate Dragon II trial of Tinlarebant for the treatm...

Belite Bio completes submission to PMDA to initiate Dragon II trial of Tinlarebant for the treatment of adolescent Stargardt disease in Japan Ophthalmology Times
Aerocrine Receives Clearance for FeNO Device in Japan - respiratory-therapy.com

Aerocrine Receives Clearance for FeNO Device in Japan respiratory-therapy.com
Convergence: Understanding expedited approval pathways in Japan - Regulatory Affairs Professional...

Convergence: Understanding expedited approval pathways in Japan Regulatory Affairs Professionals Society | RAPS
PMDA'S PROACTIVE ACTION TO ENSURE QUICK DRAINAGE OF RAINWATER IN PANCHKULA CITY - Face2News

PMDA'S PROACTIVE ACTION TO ENSURE QUICK DRAINAGE OF RAINWATER IN PANCHKULA CITY Face2News
Shape Memory Medical receives PMDA approval for the Impede-FX embolisation plug - Vascular News

Shape Memory Medical receives PMDA approval for the Impede-FX embolisation plug Vascular News
PMDA CEO inspects Panchkula city, directs removal of encroachments along roads within 3 days - Pu...

PMDA CEO inspects Panchkula city, directs removal of encroachments along roads within 3 days Punjab Newsline
Updates on Drug Regulations in Japan – Reducing Barriers to Entry for Drug Companies Entering the...

Updates on Drug Regulations in Japan – Reducing Barriers to Entry for Drug Companies Entering the Japanese Market Winston & Strawn
Breaking the speed: Pkl’s new tabletop plan aims to slow things down - Times of India

Breaking the speed: Pkl’s new tabletop plan aims to slow things down Times of India
Boston Scientific receives Japanese regulatory approval for Farapulse PFA system - Cardiac Rhythm...

Boston Scientific receives Japanese regulatory approval for Farapulse PFA system Cardiac Rhythm News
Eyes on every street: Panchkula to launch AI-powered city control centre | Hindustan Times - Hind...

Eyes on every street: Panchkula to launch AI-powered city control centre | Hindustan Times Hindustan Times
Japan keen to deepen regional partnerships, says PMDA head - BioWorld MedTech

Japan keen to deepen regional partnerships, says PMDA head BioWorld MedTech
JAPAC Drug Development: Navigating Safety & Regulatory Requirements - HIT Consultant

JAPAC Drug Development: Navigating Safety & Regulatory Requirements HIT Consultant
Panchkula gets monsoon-ready, officials directed to complete flood control measures by June 15 - ...

Panchkula gets monsoon-ready, officials directed to complete flood control measures by June 15 Times of India
Japan’s PMDA grants clearance for Priothera to commence AML therapy - Clinical Trials Arena

Japan’s PMDA grants clearance for Priothera to commence AML therapy Clinical Trials Arena
Haryana Shehar Swachhata Abhiyan: PMDA CEO Inspects Panchkula, Orders Encroachment Removal in 3 D...

Haryana Shehar Swachhata Abhiyan: PMDA CEO Inspects Panchkula, Orders Encroachment Removal in 3 Days The Hans India
Lecanemab Receives Priority Review Status in Japan - Biogen

PMDA issues rains alert for September 16-19 - Associated Press of Pakistan

PMDA issues rains alert for September 16-19 Associated Press of Pakistan
Medic Vision Wins Japanese PMDA Clearance for iQMR Image Reconstruction Solution - Imaging Techno...

Medic Vision Wins Japanese PMDA Clearance for iQMR Image Reconstruction Solution Imaging Technology News
Two darbepoetin alfa biosimilars submitted to Japan’s PMDA - Generics and Biosimilars Initiative

Two darbepoetin alfa biosimilars submitted to Japan’s PMDA Generics and Biosimilars Initiative
Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process - BioPharm I...

Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process BioPharm International
Decks cleared for recarpeting of bad roads in Panchkula - Times of India

Decks cleared for recarpeting of bad roads in Panchkula Times of India
Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemch...

Panchkula to get 'smart road' from Majri Chowk to railway station - ET Infra

Panchkula to get 'smart road' from Majri Chowk to railway station ET Infra