"PMDA" の関連情報検索結果
Lupin and YL Biologics receives PMDA approval for Etanercept biosimilar in Japan - Lupin | Press ...

Interview with MHLW and PMDA leadership - fda.gov

Expediting Drug Development in Japan: A PMDA Perspective - Wiley

Expediting Drug Development in Japan: A PMDA Perspective 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
PMDA makes case for Japan as a haven for innovation - BioWorld MedTech

PMDA makes case for Japan as a haven for innovation BioWorld MedTech
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
Japan’s PMDA completes inspection of Lupin’s Mandideep facility (Unit-2) - Lupin | Press Release ...

Japan’s PMDA completes inspection of Lupin’s Mandideep facility (Unit-2) - Lupin | Press Release lupin.com
Eisai seeks PMDA approval for subcutaneous Leqembi in Japan - Pharmaceutical Technology

Eisai seeks PMDA approval for subcutaneous Leqembi in Japan Pharmaceutical Technology
In Japan, regulatory success is built on consultation - The Pharma Letter

In Japan, regulatory success is built on consultation The Pharma Letter
Koh Young accelerates Japan push after PMDA nod with neurosurgery showcases - CHOSUNBIZ - Chosunbiz

Koh Young accelerates Japan push after PMDA nod with neurosurgery showcases - CHOSUNBIZ Chosunbiz
Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec - Yahoo Finance

Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec Yahoo Finance
Symplicity Spyral renal denervation system gains Japanese PMDA approval - Vascular News

Symplicity Spyral renal denervation system gains Japanese PMDA approval Vascular News
Nadofaragene firadenovec under regulatory review in Japan - Urology Times

Nadofaragene firadenovec under regulatory review in Japan Urology Times
Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceu...

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
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
Japan’s PMDA issues GMP Certificate to Lupin’s Unit II Mandideep facility - Lupin | Press Release...

Japan’s PMDA issues GMP Certificate to Lupin’s Unit II Mandideep facility - Lupin | Press Release lupin.com
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: 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: 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...

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
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 stocktitan.net
Asia-Pacific Roundup: India’s CDSCO halves clinical trial review timelines - Regulatory Affairs P...

Asia-Pacific Roundup: India’s CDSCO halves clinical trial review timelines Regulatory Affairs Professionals Society | RAPS
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
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
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 withdraw from plutonium agreement with the United States - Reuters

Russia moves to withdraw from plutonium agreement with the United States Reuters
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 stocktitan.net
ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes - evotec.com

ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes evotec.com
Koh Young wins Japan PMDA nod for brain surgery robot, eyes global push - CHOSUNBIZ - Chosunbiz

Koh Young wins Japan PMDA nod for brain surgery robot, eyes global push - CHOSUNBIZ Chosunbiz
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)
Russia moves to withdraw from plutonium agreement with the United States - thehindu.com

Russia moves to withdraw from plutonium agreement with the United States thehindu.com
Korea, Japan ink medical device info sharing pact - BioWorld MedTech

Korea, Japan ink medical device info sharing pact BioWorld MedTech
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
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
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
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
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
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
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
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
Two decades of new drug approvals in Japan - Nature

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
Japan offers competitive edge with clinical trial landscape and SMO approach - Clinical Trials Arena

Japan offers competitive edge with clinical trial landscape and SMO approach Clinical Trials Arena
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
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
WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again - BioSpectrum Asia

WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again BioSpectrum Asia
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
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
Japan PMDA opens second overseas office in Washington - BioWorld MedTech

Japan PMDA opens second overseas office in Washington BioWorld MedTech
PMDA, HSIIDC begin pothole repair work in Panchkula - Times of India

PMDA, HSIIDC begin pothole repair work in Panchkula Times of India
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
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
Op-ed: PMDA advances regulatory science-based “rational medicine” - foreignpolicy.com

Op-ed: PMDA advances regulatory science-based “rational medicine” foreignpolicy.com
Russia Withdraws from Critical Weapons-Grade Plutonium Deal - Discovery Alert

Russia Withdraws from Critical Weapons-Grade Plutonium Deal Discovery Alert
Biocon Biologics debuts its psoriasis biosimilar in Japan - ET Pharma

Biocon Biologics debuts its psoriasis biosimilar in Japan ET Pharma
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
PMDA’s proactive action to ensure quick drainage of rainwater in Panchkula city - The Impressive ...

PMDA’s proactive action to ensure quick drainage of rainwater in 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
JLK wins Japan’s approval for AI stroke diagnosis tool - koreabiomed.com

JLK wins Japan’s approval for AI stroke diagnosis tool koreabiomed.com
Terumo Aortic announces PMDA approval for Thoraflex Hybrid in Japan - Vascular News

Terumo Aortic announces PMDA approval for Thoraflex Hybrid 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
Aerocrine Receives Clearance for FeNO Device in Japan - respiratory-therapy.com

Aerocrine Receives Clearance for FeNO Device in Japan respiratory-therapy.com
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
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
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 announces ‘New Year gift’ for Panchkula with two mega infrastructure projects - Punjab Newsline

PMDA announces ‘New Year gift’ for Panchkula with two mega infrastructure projects Punjab Newsline
Convergence: Understanding expedited approval pathways in Japan - Regulatory Affairs Professional...

Convergence: Understanding expedited approval pathways in Japan Regulatory Affairs Professionals Society | RAPS
Japan keen to deepen regional partnerships, says PMDA head - BioWorld MedTech

Japan keen to deepen regional partnerships, says PMDA head BioWorld MedTech
PMDA Japan and Medical Device Regulation - TÜV SÜD

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
Decks cleared for recarpeting of bad roads in Panchkula - Times of India

Decks cleared for recarpeting of bad roads in Panchkula 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
Alpha Tau Submits to Japanese PMDA for Pre-Market Approval of Alpha DaRT in Patients with Recurre...

Alpha Tau Submits to Japanese PMDA for Pre-Market Approval of Alpha DaRT in Patients with Recurrent Head and Neck Cancer Yahoo Finance
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
Lecanemab Receives Priority Review Status in Japan - Biogen

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
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
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
PMDA's proactive action to ensure quick drainage of rainwater in Panchkula city - Punjab Newsline

PMDA's proactive action to ensure quick drainage of rainwater in Panchkula city Punjab Newsline
JAPAC Drug Development: Navigating Safety & Regulatory Requirements - HIT Consultant

JAPAC Drug Development: Navigating Safety & Regulatory Requirements HIT Consultant
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
Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process - BioPharm I...

Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process BioPharm International
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
Visualising PCP Metrics Using Grafana - Oracle Blogs

Visualising PCP Metrics Using Grafana Oracle Blogs
Japanese guidelines for biosimilars - Generics and Biosimilars Initiative

Japanese guidelines for biosimilars Generics and Biosimilars Initiative
LG Chem and CJ CheilJedang Join Forces to Commercialize Bio-Nylon - Lgcorp.com

LG Chem and CJ CheilJedang Join Forces to Commercialize Bio-Nylon Lgcorp.com
Current situation and issues regarding termination of risk management plans in Japan - Frontiers

Current situation and issues regarding termination of risk management plans in Japan Frontiers
PMDA Japan and Medical Device Regulation - TÜV SÜD

Sexton Biotechnologies and Ikeda Scientific Provide Human Platelet Lysate to Japanese Regenerativ...

Explainer: What is the govt's proposed media authority and why has it invited criticism? - Dawn

Explainer: What is the govt's proposed media authority and why has it invited criticism? Dawn
China And Japan Encourage Clinical Research By Streamlining Approval - Clinical Leader

China And Japan Encourage Clinical Research By Streamlining Approval Clinical Leader
Companion Diagnostics Regulations are Evolving in Asia - MedTech Intelligence

Companion Diagnostics Regulations are Evolving in Asia MedTech Intelligence
Pakistan: Government must heed media protests against controversial PMDA bill - International Fed...

Pakistan: Government must heed media protests against controversial PMDA bill International Federation of Journalists - IFJ
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
The New ICH M12 Guideline – Harmony at Last for DDI Studies! - evotec.com

The New ICH M12 Guideline – Harmony at Last for DDI Studies! evotec.com
National Cancer Center Japan and Pharmaceuticals and Medical Devices Agency Endorsed as a joint C...
