Search Results for "Food And Drug Administration Philippines Mandates"

01:51 EST 1st March 2015 | 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

ImmTAC

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...

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 ...

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...

Ebola volunteers wrestle with quarantine mandates

Dr. Robert Fuller didn't hesitate to go to Indonesia to treat survivors of the 2004 tsunami, to Haiti to help after the 2010 earthquake or to the Philippines after a devastating typhoon last year. But...

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...

Angina Treatment Nicorandil Batches Recalled

An ischaemic heart disease treatment drug has been voluntarily withdrawn from sale by a pharmaceutical firm in the Philippines on account of non-compliance issues related to recommended production and...

Philippines Leading in Regional Agri-biotech Research–USDA

USDA Foreign Agriculture Service released a report on agri-biotechnology in the Philippines. According to the report, the Philippines continues to be a regional leader in biotech research and commerci...

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...

Matching PubMed Articles

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...

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

The authors conducted a study to determine the frequency and type of adverse events (AEs) associated with dental devices reported to the Food and Drug Administration Manufacturer and User Facility Dev...

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