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15:16 EDT 27th May 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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Sanofi asked to pull vaccine ads in the Philippines

The country's Food and Drug Administration called on the French pharma to pull radio and television ads for its Dengue fever vaccine, Dengvaxia.

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...

New drug for chronic constipation approved by US Food and Drug Administration

The US Food and Drug Administration has approved plecanatide (Trulance; Synergy Pharmaceuticals) as another option for the treatment of chronic idiopathic constipation (CIC) in adults.

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…

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 ...

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...

Narcan (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration

January 25, 2017 – Dublin, Ireland – Today, the U.S. Food and Drug Administration (FDA) approved Narcan Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid ov...

Samsung Bioepis Obtains First Drug Approval in the United States, as the U.S. Food and Drug Administration Approves RENFLEXIS™ (Infliximab-abda) Across All Eligible Indications

Monday, April 24th 2017 at 5:06am UTC INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (...

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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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