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03:20 EDT 25th September 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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FDA tests confirm hepatitis A in scallops from Philippines

U.S. Food and Drug Administration tests found hepatitis A in scallops from the Philippines, which have been identified as the likely source of an outbreak of the virus in Hawaii.

#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, ...

BRIEF-Aerie Pharmaceuticals submits NDA to U.S. Food and drug administration for Rhopressa

* Submits new drug application to U.S. Food and Drug Administration for Rhopressa (netarsudil ophthalmic solution) 0.02 percent Source text for Eikon: Further company coverage:

Zymeworks’ ZW25 and ZW33 Granted Orphan Drug Designation for Ovarian Cancer by U.S. Food and Drug Administration

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-spec...

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.

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...

Idalopirdine Granted Fast Track Designation by U.S. Food and Drug Administration

Valby, 2016-07-07 15:00 CEST (GLOBE NEWSWIRE) -- H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Development & Commercialization, Inc. today announced that the U.S. Food and Drug Administrati...

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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 ...

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

321 Development of Intrathecal Riluzole: A New Route of Administration for the Treatment of Amyotrophic Lateral Sclerosis Patients.

Oral administration of riluzole is the only Food and Drug Administration-approved therapy for amyotrophic lateral sclerosis (ALS). However, per os riluzole therapy has shown modest efficacy and is lim...

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