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00:01 EDT 26th September 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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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 ...

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…

Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder)

ARDSLEY, N.Y.--(BUSINESS WIRE) June 29, 2017 -- Acorda Therapeutics, Inc. (NASDAQ: ACOR) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Inbrija (CVT-301,...

Exciton Technologies Receives Approval from China Food and Drug Administration for its Patented ...

EDMONTON, AB--(Marketwired - June 14, 2017) -Exciton Technologies has received approval from the China Food and Drug Administration (CFDA) for Exsalt®, the Company's Read more...

Scott Gottlieb to Newly Confirmed Head of the FDA & HSPH Interview with Margaret Hamburg, 21st Commissioner of the U.S. Food and Drug, 5/9/2017

Scott Gottlieb to Newly Confirmed Head of the FDA & HSPH Interview with Margaret Hamburg, 21st Commissioner of the U.S. Food and Drug, 5/9/2017 Reporter: Aviva Lev-Ari, PhD, RN   WATCH VIDEO...

Matching PubMed Articles

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.

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).

Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers: A Systematic Review.

The US Food and Drug Administration (FDA) recently issued a safety warning regarding soft-tissue fillers (STFs) based on the risk of blindness and facial necrosis.

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