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Your search keyword '"*DRUG laws"' showing total 7 results
Start Over Descriptor "*DRUG laws" Topic antineoplastic agents Journal who drug information
7 results on '"*DRUG laws"'

1. Regulatory Action and News.

Subjects
*DRUG laws, *CLINICAL trial laws, *DRUG approval laws, *ANTINEOPLASTIC agents, *ANTIBIOTICS, *HETEROCYCLIC compounds, *OXIDOREDUCTASES, *RIVAROXABAN, *ENZYME inhibitors, *PYRIDINE, *INSULIN, *CLINICAL trials, *MEDICAL laws, *LAW
Abstract

The article presents 2012 and 2013 news on regulatory action related to drugs. The U.S. Food and Drug Administration has announced that it is forming an internal task force to support development of new antibacterial drugs. Great Britain's National Institute for Biological Standards and Control will become a part of the Medicines and Healthcare products Regulatory Agency on April 1, 2013. The government of Pakistan enacted the Drug Regulatory Authority of Pakistan bill on November 12, 2012.

Published
2012

2. Trametinib and dabrafenib approved in combination for advanced melanoma.

Subjects
*ANTINEOPLASTIC agents, *ENZYME inhibitors, *MELANOMA, *DRUG laws, *LAW
Abstract

The article reports that the U.S. Food and Drug Administration (FDA) has approved trametinib (Mekinist) and dabrafenib (Tafinlar) for the treatment of patients with unresectable or metastatic melanoma.

Published
2014

3. Dabrafenib approved for metastatic melanoma.

Subjects
*ANTINEOPLASTIC agents, *MELANOMA, *DRUG laws
Abstract

The article reports on a 2013 decision which the European Medicines Agency’s Committee for Medicinal Products for Human Use made to give marketing authorization for the drug dabrafenib, which is used to treat metastatic melanoma.

Published
2013

4. Vismodegib approved for basal cell carcinoma.

Subjects
*ANTINEOPLASTIC agents, *BASAL cell carcinoma, *DRUG laws
Abstract

The article reports on a 2013 decision which the European Union's Committee for Medicinal Products for Human Use made to recommend granting a conditional marketing authorization for the drug vismodegib, which is used to treat symptomatic metastatic basal cell carcinoma.

Published
2013

5. Lapatinib: withdrawal of marketing authorization application.

Subjects
*ANTINEOPLASTIC agents, *PROTEIN kinases, *DRUG laws
Abstract

The article reports on a 2012 notification which the European Medicines Agency received from the manufacturer of the drug lapatinib regarding the manufacturer's decision to withdraw its application for a centralized marketing authorization for the drug.

Published
2012

6. Omacetaxine mepesuccinate: withdrawal of marketing authorization application.

Subjects
*ANTINEOPLASTIC agents, *ALKALOIDS, *MYELOID leukemia, *DRUG laws, *LAW
Abstract

The article reports on a 2011 notification which the European Medicines Agency received from the manufacturer of the leukemia drug omacetaxine mepesuccinate about the firm's decision to withdraw its application for centralized marketing authorization for the drug.

Published
2011

7. Gemtuzumab ozogamicin: voluntary withdrawal.

Subjects
*ANTINEOPLASTIC agents, *AMINOGLYCOSIDES, *MONOCLONAL antibodies, *MYELOID leukemia, *DRUG laws
Abstract

The article reports on a decision which the manufacturer of the cancer treatment drug gemtuzumab ozogamicin made to withdraw the drug from the U.S. market after the U.S. Food and Drug Administration raised questions about the drug's safety and efficacy.

Published
2010

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