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04:32 EDT 26th July 2017 | BioPortfolio

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Oral Administration

Abiraterone Acetate - Zytiga

On April 28, 2011, the US Food and Drug Administration (FDA) approved Zytiga (abiraterone acetate), for use in combination with prednisone for the second-line treatment of castration-resistant prost...

Food Allergy

Simultaneous Administration of Different Vaccines

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Enhancing Transparency at the US Food and Drug Administration

This Viewpoint summarizes recommendations made in a 2017 Blueprint for Transparency at the US Food and Drug Administration developed to encourage increased public access to FDA analyses and regulatory...

FDA commissioner outlines 3 focus areas for improving generics competition

David SalazarAppearing before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, Food and Drug administration commissioner Dr. Scott Gott...

FDA shocks lawmakers by pulling opioid off the market

Food and Drug Administration Commissioner Scott Gottlieb said the FDA must "take all necessary steps to reduce the scope of opioid misuse and abuse." The Food and Drug Administration shocked lawmakers...

Priority review for Lilly’s breast cancer hopeful

The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for…

Civilians seek food, water as Philippines siege continues

MARAWI, Philippines (AP) — There was food and water— welcome commodities amid the frequent tears. There was, finally, safety, at least for the moment. And there were stories — stories of things ...

Trump's pick for Food & Drug Administration garners mixed reactions

President Donald J. Trump's pick to lead the Food & Drug Administration, Scott Gottlieb, wants to get new drugs, including low-cost generics, on the market faster. A physician with leadership ...

Indian Pharma under pressure on domestic pricing issues and fears of Trump administration

Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is…

Philippines drug war under fire at UN rights council

The Philippines came under global pressure Monday over its deadly drug war, facing calls for action following an alleged wave of extrajudicial killings. Diplomats from all continents raised concern o...

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The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin.

To summarize the US Food and Drug Administration's (FDA's) review of the safety and effectiveness for pimavanserin, an atypical antipsychotic, for the treatment of hallucinations and delusions associa...

Changes in Myomectomy Practice After the U.S. Food and Drug Administration Safety Communication on Power Morcellation.

To examine the association between the 2014 U.S. Food and Drug Administration (FDA) safety communication on power morcellation and surgical approach and morbidity after myomectomy.

Trends in Mode of Hysterectomy After the U.S. Food and Drug Administration Power Morcellation Advisory.

To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines.

Medical Devices; Custom Devices; Technical Amendment. Final rule; technical amendment.

The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Fe...

Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.

To characterize the frequency, nature, and regulatory mechanisms by which ophthalmic devices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (PMA).

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