BioCentury | Apr 22, 2020
Regulation

All for one, one for all: An urgent call to harmonize global drug regulation against COVID-19

...about regulation under the auspices of the International Conference of Drug Regulatory Authorities (ICDRA). The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Sep 19, 2019
Product Development

Industry seeks ICH revisions to curb influx of irrelevant pharmacovigilance data

...noise, and revised guidelines are projected to take effect in two to three years. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...Editor AbbVie Inc. Pharmaceutical Research and Manufacturers of America (PhRMA) European Federation of Pharmaceutical Industries and Associations Parexel International Corp. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use TransCelerate...
BioCentury | Sep 6, 2019
Product Development

Growing China’s capacity to conduct high-quality trials

...on the clinical development side too, such as shortened IND review timelines and joining The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Aug 23, 2019
Company News

BeiGene's first U.S. NDA tests global development strategy

...In 2017, CFDA, a precursor to China's National Medical Products Association (NMPA), joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Aug 16, 2019
Product Development

ACRES’ plan to harmonize clinical trials across many lands

...different countries, as are ethical norms. Where international guidelines exist, such as those from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...Institutions Mentioned Alliance for Clinical Research Excellence and Safety, Cambridge, Mass. Harvard University, Cambridge, Mass. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...U.S. Department of Health and Human Services (HHS), Washington, D.C. Inhua Muijrers-Chen, Associate Editor Columbia University Harvard Medical School International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Massachusetts...
BioCentury | Aug 2, 2019
Politics & Policy

Aug. 2 P&P Quick Takes: Pediatric disease voucher guidance clarified, CMS proposes rule on hospital price transparency and draft guidance on clinical trial prac

...draft guidance on general considerations for clinical trials FDA released a draft guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | May 17, 2019
Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

...companies. In June 2017, China's National Medical Products Administration (NMPA) became a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Feb 26, 2019
Politics & Policy

FDA publishes continuous manufacturing guidance

...have engaged with FDA to develop continuous manufacturing platforms. Gottlieb and Woodcock said the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Dec 14, 2018
Tools & Techniques

Bigger sandbox for in silico tox

...for Tox” ). In a guidance document drafted in 2014 and finalized this March, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...have endorsed using them in regulatory submissions to predict whether compound impurities are mutagenic. An International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...causing confidentiality issues.” Companies and Institutions Mentioned ForthTox Ltd., Linlithgow, U.K. Health Canada, Ottawa, Ontario International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Oct 19, 2018
Politics & Policy

FDA asks peers to globalize generic drug development

...and applications to gain approval across multiple jurisdictions. The agency submitted its proposal to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
Items per page:
1 - 10 of 28
BioCentury | Apr 22, 2020
Regulation

All for one, one for all: An urgent call to harmonize global drug regulation against COVID-19

...about regulation under the auspices of the International Conference of Drug Regulatory Authorities (ICDRA). The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Sep 19, 2019
Product Development

Industry seeks ICH revisions to curb influx of irrelevant pharmacovigilance data

...noise, and revised guidelines are projected to take effect in two to three years. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...Editor AbbVie Inc. Pharmaceutical Research and Manufacturers of America (PhRMA) European Federation of Pharmaceutical Industries and Associations Parexel International Corp. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use TransCelerate...
BioCentury | Sep 6, 2019
Product Development

Growing China’s capacity to conduct high-quality trials

...on the clinical development side too, such as shortened IND review timelines and joining The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Aug 23, 2019
Company News

BeiGene's first U.S. NDA tests global development strategy

...In 2017, CFDA, a precursor to China's National Medical Products Association (NMPA), joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Aug 16, 2019
Product Development

ACRES’ plan to harmonize clinical trials across many lands

...different countries, as are ethical norms. Where international guidelines exist, such as those from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...Institutions Mentioned Alliance for Clinical Research Excellence and Safety, Cambridge, Mass. Harvard University, Cambridge, Mass. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...U.S. Department of Health and Human Services (HHS), Washington, D.C. Inhua Muijrers-Chen, Associate Editor Columbia University Harvard Medical School International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Massachusetts...
BioCentury | Aug 2, 2019
Politics & Policy

Aug. 2 P&P Quick Takes: Pediatric disease voucher guidance clarified, CMS proposes rule on hospital price transparency and draft guidance on clinical trial prac

...draft guidance on general considerations for clinical trials FDA released a draft guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | May 17, 2019
Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

...companies. In June 2017, China's National Medical Products Administration (NMPA) became a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Feb 26, 2019
Politics & Policy

FDA publishes continuous manufacturing guidance

...have engaged with FDA to develop continuous manufacturing platforms. Gottlieb and Woodcock said the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Dec 14, 2018
Tools & Techniques

Bigger sandbox for in silico tox

...for Tox” ). In a guidance document drafted in 2014 and finalized this March, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...have endorsed using them in regulatory submissions to predict whether compound impurities are mutagenic. An International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
...causing confidentiality issues.” Companies and Institutions Mentioned ForthTox Ltd., Linlithgow, U.K. Health Canada, Ottawa, Ontario International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
BioCentury | Oct 19, 2018
Politics & Policy

FDA asks peers to globalize generic drug development

...and applications to gain approval across multiple jurisdictions. The agency submitted its proposal to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
Items per page:
1 - 10 of 28