Search Results for "Food And Drug Administration Philippines Mandates"

05:25 EST 26th January 2015 | BioPortfolio

Original Source: Improving the Food and Drug Administration's mandate to ensure postmarketing drug safety.

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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


Immunocore’s ImmTAC technology enables the immune system to recognise and kill cancer or viral cells. T Cell Receptors naturally recognise diseased cells and Immunocore’s competitive ad...

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Philippines Consults On ASEAN Medtech Regulatory Plans

The Philippines Food and Drug Administration is inviting feedback from stakeholders on its proposal to adopt new documentary requirements for the registration of medical devices based on the ASEAN Med...

US Food and Drug Administration and Design of Drug Approval Studies

To enhance protocol quality, federal regulations encourage but do not require meetings between pharmaceutical companies and the US Food and Drug Administration (FDA) during the design phase of pivotal...

OEP Philippines Orders Recall Of Angina Drug

OEP Philippines has ordered a recall of batches of its Aprior (nicorandil) drug for treating angina after samples were found by the Italian Medicines Agency to have failed good manufacturing practice ...

China Food and Drug Administration approves SciClone and BTG's DC Bead

SciClone Pharmaceuticals and its partner BTG has announced that the China Food and Drug Administration has approved the registration of DC Bead for the embolization of malignant hypervascularized tumo...

Codman’s REVIVE SE Thrombectomy Device receives approval in China, Taiwan, South Korea

Codman Neuro’s REVIVE SE Thrombectomy Device has received approval from the China Food and Drug Administration (CFDA), South Korea's Ministry of Food and Drug Safety (MFDS), and Taiwan Food and Drug...

FDA Guards Against Food Spoilage, Contamination

Food and Drug Administration analysts and entomologists investigate product samples and protect consumers from spoiled and contaminated food.

FDA Cautions Against 'Undeclared' Food Allergens

TUESDAY, Oct. 28, 2014 -- Some food labels may not reliably list all possible food allergens, according to the U.S. Food and Drug Administration. The agency added that these "undeclared allergens" are...

Par Pharmaceutical gets FDA approval of Vasostrict

Par Pharmaceutical has received approval for its new drug application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the US Food and Drug Administration (FDA) pursuant to section 5...

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Demystifying the u.s. Food and drug administration: I. Understanding agency structure and function.

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologi...

Food and Drug Administration Responds to Pressure for Expanded Drug Access.

Postmarketing Review of Intravenous Acetaminophen Dosing Based on Food and Drug Administration Prescribing Guidelines.

To evaluate the appropriateness of intravenous acetaminophen dosing-prescribed dose, frequency, duration, and indication-based on United States Food and Drug Administration (FDA)-approved prescribing ...

Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval: FDA-Mandated Postapproval Studies.

Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to cond...

Drug Development and FDA Approval, 1938-2013.

This interactive graphic shows major legislative and regulatory events related to approval of new drugs by the Food and Drug Administration (FDA), drug approvals by year and by therapeutic category, a...

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