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Latest Food and Drug Administration Stories

2014-10-16 12:30:21

First FDA Approved Treatments in United States for Devastating Lung Disease Affecting More than 200,000 Americans, with Survival Rate of Just Three to Five Years CHICAGO, Oct. 16, 2014 /PRNewswire-USNewswire/ -- The Pulmonary Fibrosis Foundation (PFF) applauds the approval of Esbriet(®) (pirfenidone) and OFEV(®) (nintedanib) by the U.S. Food and Drug Administration (FDA) as the first disease-specific therapies for idiopathic pulmonary fibrosis (IPF) in the United States....

2014-10-16 08:31:22

DUBLIN, Oct. 16, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5 mg/mL. Actavis' ANDA product is a generic version of Pfizer and Tris Pharma's Quillivant XR(®), which is a central nervous system stimulant indicated for the treatment of Attention Deficit...

2014-10-16 08:30:28

ST. LOUIS, Oct. 16, 2014 /PRNewswire/ -- BioReliance(®) (www.bioreliance.com), Sigma-Aldrich Corporation's (NASDAQ: SIAL) biologics and early-development services business under SAFC(®) Commercial (www.sigmaaldrich.com/safc), has introduced select in vitro ADME (absorption, distribution, metabolism and excretion) and toxicology testing services for pharmaceutical, chemical and industrial consumer products to its service offering. The broad set of highly predictive assays use a novel...

2014-10-15 23:11:30

On October 10, the FDA announced that several lots of CareFusion 203, EnVe and ReVel ventilators are recalled due to power connection failure. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 15, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on EnVe and ReVel ventilators. The US FDA announced on...

2014-10-15 23:02:20

The Firm is evaluating potential morcellator lawsuits on behalf of women who allegedly experienced the spread of uterine sarcoma and other cancers due to the use of power morcellators in laparoscopic hysterectomy and fibroid removal. New York, NY (PRWEB) October 15, 2014 Federal health regulators investigating the potential link between the use of power morcellators (http://www.injurybeacon.com/power-morcellator/) and the spread of undiagnosed uterine sarcoma and other cancers are not...

2014-10-15 23:01:54

mediStat Specialized Pharmacy today announced it has voluntarily registered with the US Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility under section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. Foley, AL (PRWEB) October 15, 2014 mediStat Specialized Pharmacy today announced it has voluntarily registered with the US Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility under section 503B of the Federal Food,...

2014-10-15 16:30:17

Introduces Chairman Gewanter, shows support for BQ proposal GENEVA, Oct. 15, 2014 /PRNewswire/ -- The Alliance for Safe Biologic Medicines (ASBM) presented at the World Health Organization's (WHO) 59(th) International Nonproprietary Naming Stakeholders Session on Tuesday, October 14, 2014. This was the third time ASBM presented to the WHO but the first appearance for ASBM's new chairman Dr. Harry L. Gewanter. As a practicing pediatric rheumatologist and ASBM International Advisory...

2014-10-15 12:32:31

LONDON, Oct. 15. 30, 2014 /PRNewswire/ -- REPORT HIGHLIGHTS The global market for ADC drugs reached $179 million in 2012 and $396 million in 2013. The market should reach $2.8 billion in 2018 with a compound annual growth rate (CAGR) of 48.1%. This report provides:An overview of the global market for ADCs as a part of the pharmaceutical industry that is looking for innovative technologies.Analyses of global market trends, with data from 2012, 2013, and projections of compound annual...

2014-10-15 12:27:56

Experts team-up to help keep quality medicines available to those who need them TAMPA, Fla., Oct. 15, 2014 /PRNewswire-USNewswire/ -- ISPE, the International Society for Pharmaceutical Engineering, released its Drug Shortages Prevention Plan at its 2014 Annual Meeting in Las Vegas, Nevada. Regulators from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Medicines and Healthcare Products Regulatory Agency (MHRA), welcomed the Plan and spoke...

2014-10-14 23:14:04

On October 8, the FDA announced that one lot of Vancomycin Hydrochloride for Injection, USP, by Hospira Inc., is recalled due to uncontrolled storage during transit. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 14, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Vancomycin Hydrochloride. The...


Latest Food and Drug Administration Reference Libraries

Flavr Savr
2013-10-03 09:43:32

Flavr Savr, also known as CGN-89564, a genetically modified tomato, was the first commercially grown genetically engineered food to be granted a license for human consumption. It was produced by the Californian company Calgene, and submitted to the U.S. Food and Drug Administration in 1992. On May 18, 1994, the FDA completed its evaluation of the Flavr Savr tomato and the usage of APH(3’)II, concluding that the tomato “is as safe as tomatoes bred by conventional means” and “that the...

Chilean Sea Bass, Dissostichus eleginoides
2013-01-12 08:49:28

The Chilean sea bass is the North American name for the Patagonian toothfish. The Chilean sea bass name derived in 1977 from Lee Lantz, a fish wholesaler looking for a more attractive name for the American fish market. In 1994 the Food and Drug Administration (FDA) accepted the Chilean sea bass as an alternative name for the Patagonian toothfish. This species is native to the southern Pacific, Atlantic, and Indian Oceans, around seamounts and continental shelves in the colder waters. The...

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Word of the Day
conjunto
  • A style of popular dance music originating along the border between Texas and Mexico, characterized by the use of accordion, drums, and 12-string bass guitar and traditionally based on polka, waltz, and bolero rhythms.
The word 'conjunto' comes through Spanish, from Latin coniūnctus, past participle of coniungere, to join together; see conjoin