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Latest Food and Drug Administration Stories

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...

2014-10-14 20:22:09

LONDON, Oct. 14, 2014 /PRNewswire/ -- This BCC Research study offers an overview of the multiple sclerosis (MS) disease-modifying product market, including regulatory issues accompanied by detailed analyses and forecasts by product. Its main objective is to present a comprehensive analysis of the current market for MS disease-modifying products and to forecast this marketâEUR(TM)s future direction through 2018. Special focus is placed on how new products and technologies will affect...

2014-10-14 16:28:40

CASTLE ROCK, Colo., Oct. 14, 2014 /PRNewswire/ -- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1(TM) Test, a rapid blood test for aiding in identifying children, adolescent, and young adult patients in the emergency room who are at low probability for appendicitis, today announced that results of the company's pivotal APPY1 clinical trial will be presented by Dr. David S. Huckins, M.D., Lead...

2014-10-14 16:28:30

SAN DIEGO, Oct. 14, 2014 /PRNewswire/ -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), an oncology company developing new treatments for cancer and associated pain, announced today positive results from recently analyzed pharmacokinetic (PK) data from the first eight (8) patients enrolled in its ongoing TRIBECA(TM) (TRIal establishing BE between Cynviloq(TM) and Albumin-bound paclitaxel) registrational trial. The data from these patients supports earlier completion of the...

2014-10-14 16:28:25

Robert W. Pollock Named President MOUNTAIN VIEW, Calif., Oct. 14, 2014 /PRNewswire/ -- Melbourne Laboratories(TM) announced today the appointment of Robert W. Pollock as the Company's founding President and Chief Scientific Officer. Pollock joins Melbourne from Lachman Consulting Services, where he had a distinguished 20-year career working with industry to address a myriad of regulatory, compliance and development issues. Prior to Lachman Pollock was with the United States Public...

2014-10-14 12:29:07

WASHINGTON, Oct. 14, 2014 /PRNewswire-USNewswire/ -- The following is a statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids: A new report issued today shows that the United States has fallen far behind much of the world in requiring large, graphic health warnings on cigarette packs. The report should spur the Food and Drug Administration to quickly develop and implement such warnings, as required by U.S. law. The U.S. is tied for last among 198...

2014-10-13 23:08:53

U.S. Food and Drug Administration selects DRT Strategies as the sole prime contractor for its five-year, Blanket Purchase Agreement to provide CDRH Information Management Support services. Arlington, Virgina (PRWEB) October 13, 2014 DRT Strategies, Inc. (DRT) (http://www.drtstrategies.com), a leading management and technology consulting firm to federal agencies, the U. S. Navy, and commercial technology and financial services clients, announced today that the U.S. Food and Drug...

2014-10-13 23:08:33

On October 8, the FDA announced that SAM Junctional Tourniquet Accessory (Axilla) Strap, by SAM Medical Products, is recalled due to potential clip 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 13, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Junctional Tourniquet. The US FDA...

2014-10-13 23:07:03

Expert speaker Dr. David Lim will shed light on the FDA’s regulatory requirements for a medical device design control system in a 60-minute LIVE audio session at AudioEducator.com. Don’t miss out on this opportunity! Durham, NC (PRWEB) October 13, 2014 In the medical device industry regulatory compliance is serious business. There is a lot at stake, from patient safety to company reputations, negative publicity to hefty fines in case of negligence. Quality management needs to be 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
ramage
  • Boughs or branches.
  • Warbling of birds in trees.
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