Search Results for "Food And Drug Administration Philippines Mandates"

10:29 EDT 2nd October 2014 | 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...

First Lady To Fight Efforts To Weaken School Lunch Mandates

Meanwhile, Food and Drug Administration officials are told by a Senate committee to seek input from physicians, patients and pharmacists before putting out new guidelines for compounding pharmacies. T...

Philippines Drug Distributor Recalls Drug Used In Acute Heart Failure

The Philippines FDA said drug distributor I.E. Medica is recalling several batches of dobutamine injectable for treating acute heart failure after finding an unusual color in the drug produced by Ind...

AbbVie Receives Orphan Drug Designation for HUMIRA (adalimumab) from the U.S. Food and Drug Administration for the Investigational Treatment of Certain Forms of Non-infectious Uveitis

NORTH CHICAGO, Ill., May 20, 2014 /PRNewswire/ --AbbVie (NYSE:ABBV) announced today that the U.S. Food and Drug Administration (FDA) has granted HUMIRA® (adalimumab) orphan drug designation for th...

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 ...

Feeding Fido Raw Pet Food a Risky Choice: FDA

TUESDAY, July 1, 2014 -- You may think you're doing what's best for your beloved pets when you feed them raw food, but you're actually putting their health -- and yours -- at risk, the U.S. Food and D...

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...

Abbott Recalls Batch Of Anti-Platelet Drug In Philippines Due To Smell

Abbott Laboratories issued a recall of a batch of its platelet-inhibitor drug, Triflusal (trifluoromethyl), from the Philippines market after some capsules of it were found to be malodorous.

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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.

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...

Implications of the FDA statement on transvaginal placement of mesh: the aftermath.

The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstructi...

Changes in State Prescription Contraceptive Mandates For Insurers: The Effect on Women's Contraceptive Use.

Access to effective contraceptives is critical to reducing levels of unintended childbearing in the United States. Since 1998, more than half the states have passed legislation requiring insurers that...

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