Suchergebnisse - "REGULATORY approval"

Cell and gene therapy approvals in Asia: regulatory landscape, access and affordability.

Autoren: Hwang, William Ying Khee Bari, Sudipto Kawamata, Shin et al.

Quelle: Cytotherapy (Elsevier Inc.). Dec2025, Vol. 27 Issue 12, p1363-1374. 12p.

Schlagwörter: *GENE therapy, *REGULATORY approval, *REIMBURSEMENT, *PRICE fluctuations, *HEALTH services accessibility, *SOUTHEAST Asians

Geografische Kategorien: ASIA, JAPAN, CHINA, INDIA, SOUTH Korea

中国创新药械政策进展与思考.

Alternate Title: Progress and reflections on policy of innovation pharmaceuticals and medical devices in China.

Autoren: 蔺　淼 费永和 崔俐俊 et al.

Quelle: Journal of Pharmaceutical Practice & Service. 11/25/2025, Vol. 43 Issue 11, p577-582. 6p.

Schlagwörter: *PHARMACEUTICAL industry, *REGULATORY approval, *TECHNOLOGICAL innovations, *POLICY sciences, *MARKET entry, *MEDICAL equipment, *DRUGS, *REIMBURSEMENT

Geografische Kategorien: CHINA

Mitomycin Intravesical Solution: First Approval.

Autoren: Keam, Susan J.¹ (AUTHOR) cdi@adis.com

Quelle: Clinical Drug Investigation. Nov2025, Vol. 45 Issue 11, p909-913. 5p.

Schlagwörter: *NON-muscle invasive bladder cancer, *REGULATORY approval, *THERAPEUTICS, *MITOMYCINS, *PHARMACEUTICAL industry, *HYDROGELS, *BLADDER cancer

Assessing the sensitisation hazard of microbial pesticides: potential value of New Approach Methodologies (NAMs) to overcome current challenges.

Autoren: Leme, Daniela Morais Pestana, Cynthia Bomfim Kenny, Elaine F. et al.

Quelle: Archives of Toxicology. Nov2025, Vol. 99 Issue 11, p4337-4351. 15p.

Schlagwörter: *BIOPESTICIDES, *REGULATORY approval, *EVALUATION methodology, *EVALUATION research, *SUSTAINABILITY, *ALLERGENS, *SCIENTIFIC knowledge

Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024.

Autoren: Almeida, Diogo Mandslay, Diana Mol, Peter G. M. et al.

Quelle: BioDrugs. Nov2025, Vol. 39 Issue 6, p927-941. 15p.

Schlagwörter: *REGULATORY approval, *PATIENT reported outcome measures, *SAFETY, *TREATMENT effectiveness, *REGENERATIVE medicine, *EMPIRICAL research

Firma/Körperschaft: EUROPEAN Union , EUROPEAN Commission , EUROPEAN Medicines Agency

GMO approvals under pressure: How climate shocks shape policy across nations.

Autoren: Kong, Xiangwen¹ (AUTHOR) xzk0006@auburn.edu

Quelle: PLoS ONE. 10/22/2025, Vol. 20 Issue 10, p1-20. 20p.

Schlagwörter: *CLIMATE change, *REGULATORY approval, *AGRICULTURE, *TRANSGENIC seeds, *GOVERNMENT regulation, *GOVERNMENT policy, *AGRICULTURAL ecology

Minnesota’s Assisted Living License: Engagement of Small Assisted Living Providers.

Autoren: Moone, Rajean P. Hakanson, Megan Shippee, Tetyana Pylypiv

Quelle: Journal of Aging & Social Policy. Oct2025, p1-17. 17p. 1 Illustration.

Schlagwörter: *STAKEHOLDER analysis, *REGULATORY approval, *CULTURAL pluralism, *MEDICAID eligibility, *POLICY sciences, *CONGREGATE housing

Geografische Kategorien: MINNESOTA

Harmonising Global Regulatory Requirements for Biologicals.

Autoren: Bhavani, R. Deeksha Raghava, D. Rao, K. Nageswara et al.

Quelle: Journal of Cardiovascular Disease Research (Journal of Cardiovascular Disease Research). 2025, Vol. 16 Issue 10, p58-65. 8p.

Schlagwörter: *BIOLOGICAL products, *REGULATORY approval, *QUALITY assurance, *SAFETY regulations, *QUALITY standards, *STANDARDS, *MONOCLONAL antibodies, *VACCINES

Geografische Kategorien: EUROPE, INDIA

Firma/Körperschaft: UNITED States. Food & Drug Administration , EUROPEAN Medicines Agency

Assessment of the official national insurance coverage of regenerative medical products for ophthalmic diseases in Japan following regulatory approval

Autoren: Kenichi Kimura Kojiro Imai Morio Ueno et al.

Quelle: Regen Ther
Regenerative Therapy, Vol 30, Iss, Pp 384-388 (2025)

Schlagwörter: Medicine (General), R5-920, QH573-671, Central Social Insurance Medical Council in Japan, Regulatory approval, Insurance coverage, Ophthalmic regenerative medical products, Cytology, Article

Zugangs-URL: https://doaj.org/article/7938f9847ad54e119ad9eea8799c1b90

Auswahl des Veranstalters des München Marathon ist rechtlich nicht zu beanstanden.

Autoren: c. t.

Quelle: Fundstelle Baden-Württemberg. nov2025, Vol. 78 Issue 21, p891-895. 5p.

Schlagwörter: *REGULATORY approval, *MARATHONS (Sports), *GOVERNMENT regulation, *EVENT management

Zur Erlaubnis nach § 29 StVO -- Auswahl des Veranstalters eines Marathons ist rechtlich nicht zu beanstanden.

Quelle: Fundstelle Baden-Württemberg. okt2025, Vol. 78 Issue 20, p864-868. 5p.

Schlagwörter: *MARATHONS (Sports), *REGULATORY approval, *MARATHON running, *TRAFFIC regulations, *TRAFFIC flow, *EVENT management, *PUBLIC safety

Exploring the challenges faced by generic version of complex drugs: a scoping review.

Autoren: Sreedevi, Amatha Raj, Elstin Anbu Sreedhar, D. et al.

Quelle: Systematic Reviews. 9/29/2025, Vol. 14 Issue 1, p1-19. 19p.

Schlagwörter: *REGULATORY approval, *ARTIFICIAL intelligence, *STAKEHOLDER theory, *PRODUCT attributes, *EVALUATION methodology, *DRUGS

Developing Biosimilars: Challenges and Opportunities.

Autoren: Sinha, Shubhadeep Raphael, Ruby

Quelle: Pharmaceutical Medicine. Sep2025, Vol. 39 Issue 5, p341-352. 12p.

Schlagwörter: *BIOSIMILARS, *REGULATORY approval, *BIOLOGICALS, *DRUGS, *RESOURCE allocation, *HEALTH services accessibility, *PATIENT care

Regulatory Disparities Between US Accelerated Approval and Japanese Authorization of Oncology Drugs: An Analysis of Evidence Quality.

Autoren: Iwata, Maho Murayama, Anju

Quelle: CTS: Clinical & Translational Science. Sep2025, Vol. 18 Issue 9, p1-5. 5p.

Schlagwörter: *REGULATORY approval, *TREATMENT effectiveness, *EMPIRICAL research, *GOVERNMENT agencies, *ANTINEOPLASTIC agents

Geografische Kategorien: UNITED States, JAPAN

Firma/Körperschaft: UNITED States. Food & Drug Administration

Assessment of genetically modified cotton GHB614 × LLCotton25 for renewal authorisation under regulation (EC) No 1829/2003 (dossier GMFF‐2024‐21890).

Autoren: Casacuberta, Josep Barro, Francisco Braeuning, Albert et al.

Quelle: EFSA Journal. Aug2025, Vol. 23 Issue 8, p1-11. 11p.

Schlagwörter: *RISK assessment, *REGULATORY approval, *TRANSGENIC organisms, *ENVIRONMENTAL monitoring, *HERBICIDE tolerance of plants

Firma/Körperschaft: EUROPEAN Union , EUROPEAN Food Safety Authority , EUROPEAN Commission

Meta‐analysis on effects of Bt‐maize on nontarget invertebrates – Data transportability across continents.

Autoren: Meissle, Michael Naranjo, Steven E. Romeis, Jörg

Quelle: Plants, People, Planet. Jul2025, p1. 12p. 7 Illustrations.

Schlagwörter: *NON-target organisms, *REGULATORY approval, *KNOWLEDGE transfer, *ENVIRONMENTAL risk assessment, *TRANSGENIC plants, *INTEGRATED pest control

Geografische Kategorien: EUROPE

Barriers and hurdles delaying governance approval for an ethically approved nationwide clinical trial in pancreatic cancer.

Autoren: Recasens, Ariadna Li, Lin Ioannou, Liane et al.

Quelle: ANZ Journal of Surgery. Jul2025, Vol. 95 Issue 7, p1470-1476. 7p.

Schlagwörter: *PANCREATIC cancer, *REGULATORY approval, *CLINICAL trials, *INSTITUTIONAL review boards, *MEDICAL research, *CLINICAL governance

Geografische Kategorien: AUSTRALIA

Aon head of UK retirement policy gains new CDC qualification.

Autoren: Simon, Emma

Quelle: Corporate Adviser (Online Edition). 10/2/2025, p1-2. 2p.

Schlagwörter: *RETIREMENT policies, *REGULATORY approval, *ACTUARIES, *PROFESSIONS, PROFESSIONALISM

Orkla's India unit IPO opens next week.

Autoren: Mishra, Shivam (AUTHOR)

Quelle: Aroq - Just-Food.com (Global News). 10/24/2025, pN.PAG-N.PAG. 1p.

Schlagwörter: *GOING public (Securities), *REGULATORY approval, *BRAND name products, CONVENIENCE foods, SPICES

Geografische Kategorien: INDIA

Firma/Körperschaft: ORKLA ASA

Briefing: Reducing regulatory turbulence for US offshore wind development.

Autoren: Smead, Mathew Xydis, George

Quelle: Proceedings of the Institution of Civil Engineers: Engineering Sustainability. Jun2025, Vol. 178 Issue 3, p164-170. 7p.

Schlagwörter: *OFFSHORE wind power plants, *REGULATORY approval, *ADMINISTRATIVE procedure, *ENERGY policy, *RESOURCE allocation, *INDUSTRIAL expansion, *GOVERNMENT agencies

Geografische Kategorien: UNITED States

Firma/Körperschaft: UNITED States. Bureau of Ocean Energy Management, Regulation & Enforcement