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05:32 EDT 31st July 2016 | 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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#jobs #lifescience U.S. Food and Drug Administration: Principal Investigator Positions at the U.S. Food and Drug Administration

// Undisclosed: U.S. Food and Drug Administration: Recruiting for three qualified and motivated individuals, with Ph.D. and/or M.D. degrees, for career-conditional PI positions … Silver Spring, ...

FDA Mandates Essure Black Box Warning, More Safety Studies

After months of deliberation, the U.S. Food and Drug Administration announced it is mandating stronger warnings and more studies for Bayer’s controversial Essure Permanent Birth Control device. ...

Prime Therapeutics Statement On U.S. Food And Drug Administration's Approval Of Biosimilar Inflectra

The U.S. Food and Drug Administration's (FDA) approval yesterday of the second U.S. biosimilar, Inflectra™(infliximab-dyyb), is a positive step in the pursuit of affordable drug prices.

FDA Mandates New Warnings, New Data for Essure Contraceptive Device

(CNN) – The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. A black box warning in t...

US Food and Drug Administration approves biosimilar drug for multiple conditions including rheumatoid arthritis

The Food and Drug Administration (FDA), in the US, has approved Celltrion’s Inflectra (infliximab-dyyb) – a biosimilar to infliximab – for multiple conditions, including rheumatoid arthritis and...

Food and Drug Administration takes steps to ensure safety of Essure

The Food and Drug Administration has taken steps to ensure the safety of the Essure method of permanent birth control. The agency has issued a new, mandatory clinical study to determine heightened r...

Statement on HHS OIG Early Alert on FDA food recall initiation process

Public health is our top priority and the U.S. Food and Drug Administration works hard to ensure the U.S. food supply remains among the safest in the world.

Venus Concept Receives Clearance by U.S. Food and Drug Administration for Venus Versa™ for over 20 Common Clinical Indications

Toronto, Ontario (PRWEB) March 24, 2016 Venus Concept, a leading global medical device company, announced today that the Venus Versa...

Matching PubMed Articles

Impact of a US Food and Drug Administration Drug Safety Communication on Zolpidem Dosing: An Observational Retrospective Cohort.

Zolpidem is a sedative-hypnotic widely prescribed in the United States. Recently, the US Food and Drug Administration (FDA) issued a drug safety communication regarding its dosing in women.

Food and Drug Administration Drug Approval Process: A History and Overview.

In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administrati...

Pediatric registries at the Food and Drug Administration: design aspects that increase their likelihood of success.

To determine aspects of the design of pediatric registries that contribute to the success of registries conducted as a postmarketing study following approval of drugs or biological products by the US ...

Transvaginal mesh in the media following the 2011 US food and drug administration public health notification update.

Prompted by patients' changing perceptions of transvaginal mesh, this study examines how mesh has been reported in the news following the 2011 US Food and Drug Administration (FDA) updated notificatio...

Reporting Cosmetic Adverse Events to the US Food and Drug Administration.

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