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Search Results for "Food And Drug Administration Philippines Mandates"

08:21 EDT 19th April 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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Are enough women included in medical device studies, as required by the FDA?

(Mary Ann Liebert, Inc./Genetic Engineering News) The US Food and Drug Administration mandates adequate enrollment of women in post-approval studies of medical devices to ensure that any sex differenc...

FDA mandates enrollment and monitoring of women in post-approval studies for medical devices

The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectivenes...

We must restrain our penchant for bans and mandates in health care

Legislative bodies are moving with unprecedented swiftness to ensure we lead healthier lives. From bans on soda to bans on fast food, from mandates on health insurance coverage to mandates on EM...

How is the U.S. Food and Drug Administration Preparing for the Era of Personalized Medicine?

In an October 2013 report, the U.S. Food and Drug Administration (FDA) highlighted the regulatory challenges of personalized therapeutics, as well as the agency’s response.1 Overall, the report demo...

BRIEF-U.S.FDA approves J&J's Olysio to treat chronic Hep C infection

Nov 22 (Reuters) - U.S. Food and Drug Administration: * U.S. Food and Drug Administration says approved Olysio (simeprevir), a new

Philippines FDA Recalls China Firm's Misbranded Anti-Bacterial Drug

The Philippines FDA ordered a recall of Ningbo Tisun Medic Biochemical-China's antibacterial drug Cefazolin (cefazin) powder injectable over misbranding issues.

Proposed changes to nutrition labels and marketing food to children

The nutrition labels on packaged food and beverages may be due a makeover, thanks to proposals from the Food and Drug Administration. The agency is accepting public comment on the proposed changes for...

All FDA drug approvals not created equal

(Yale University) Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the federal Food and Drug Administration -- but a new study by res...

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Analysis of US Food and Drug Administration Warning Letters: False Promotional Claims Relating to Prescription and Over-the-Counter Medications.

Recent studies have suggested that there has been an increase in the number of 'warning letters' issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guid...

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...

Comparison and Overview of Currently Available Neurotoxins.

Background: Botulinum toxin has been in use since the 1970s. Over the last few years, the indications for botulinum toxin use have extended for cosmetic and noncosmetic applications. Three preparation...

Pain palliation measurement in cancer clinical trials: The US Food and Drug Administration perspective.

Pain palliation resulting from antitumor therapy provides direct evidence of treatment benefit when combined with evidence of antitumor activity. The US Food and Drug Administration (FDA) previously i...

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