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Latest Food and Drug Administration Stories

2014-09-30 23:24:17

As Pradaxa Lawsuit Claims Continue Boehringer Ingelheim Conducts Clinical Trials On Idarucizumab, A Potential Reversal Agent To Pradaxa Columbus, OH (PRWEB) September 30, 2014 Wright & Schulte LLC has learned that Boehringer Ingelheim Pharmaceuticals, Inc. is testing a possible antidote for Pradaxa, the company’s oral anticoagulant that is the focus of almost 2500 Pradaxa lawsuits pending in the U.S. District Court, Southern District of Illinois alleging uncontrollable bleeding. The...

2014-09-30 23:23:50

For generic drugmakers, Oct. 1 is crunch time, the date after which all ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012. Joan Janulis, a Hatch-Waxman pro and all-around expert on FDA regulation in the generic drug industry, will help attendees read between the lines of the GDUFA performance metrics, associated guidance documents and MAPPs, and provide a roadmap to the post-GDUFA paradigm....

2014-09-30 23:23:48

Having FDA-regulated products held at ports costs time, money and the competitive edge. Here’s the one interactive workshop that arms attendees with a full program of today’s best compliance strategies for speeding products out of Customs and into US and global markets. Falls Church, VA (PRWEB) September 30, 2014 Building a World-Class Import/Export Program: How to Comply with the FDA and US Customs **Presented Encore Insight LLC and FDAnews** Oct. 27-28, 2014 – Bethesda, MD...

2014-09-30 23:16:39

The Long Island law firm of Rudolph F. X. Migliore, P. C. discusses experts claims that aggressive marketing tactics spiked false diagnosis of low testosterone in male patients. (PRWEB) September 30, 2014 The Federal Court System has assigned all lawsuits relating to low testosterone drugs and heart attacks to the Southern District of Illinois (In re Testosterone Replacement Therapy Products Liability Litigation, MDL 2545). Progress on the cases is being made and the most recent case...

2014-09-30 23:13:09

Transparency Market Research has published a new report titled "Biological Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020" to its report database. Albany, New York (PRWEB) September 30, 2014 The biological drugs market encompasses a class of medicine that is developed through genetic modification of monoclonal antibodies. Monoclonal antibodies naturally inhabit the human immune system and help the body in fighting from a variety of...

2014-09-30 20:23:13

OTTAWA, Sept. 30, 2014 /CNW/ - Protecting the health and safety of Canadians is our government's highest priority. Our expectation is that Health Canada uses the appropriate powers and tools at its disposal to help ensure that the drugs Canadians need meet the highest safety and quality standards. To that end, Health Canada has taken decisive action today to stop the import into Canada of all drug products from three plants in India. They are: -- Apotex Pharmachem India Pvt Ltd --...

2014-09-30 20:23:12

OTTAWA, Sept. 30, 2014 /CNW/ - Health Canada took action today to stop the import of health products from the following sites in India: -- Apotex Pharmachem India Pvt Ltd (APIPL) -- Apotex Research Private Limited (ARPL) -- IPCA Laboratories The action applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA. Health Canada has compiled an initial list of products affected by the import ban....

2014-09-30 16:28:04

Growth Capital Allows Alimera to Fulfill Its Milestone Obligation Triggered by FDA Approval of ILUVIEN® ATLANTA, Sept. 30, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that it has received a $25 million advance from Hercules Technology Growth Capital, Inc. (NYSE: HTGC) (Hercules). The payment is the second...

2014-09-30 12:30:18

LAVAL, Quebec, Sept. 30, 2014 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that the company's Bridgewater, New Jersey location received a Warning Letter from the U.S. Food and Drug Administration (FDA) relating to an inspection in June 2014 of the Company's records with regards to Sculptra Aesthetic injectable, which was divested to Galderma S.A. in July 2014. The Warning Letter pertains to the management of Valeant's contract...

2014-09-30 08:30:41

MUMBAI, September 30, 2014 /PRNewswire/ -- China's regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. The country's new leaders have recognized that the regulations for supervision and administration of in-vitro diagnostic reagents are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest "Regulations for the Supervision and Administration of Medical...


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
bellycheer
  • Good cheer; viands.
  • To revel; to feast.
The word 'bellycheer' may come from 'belle cheer', "good cheer".
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