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Latest FDA Stories

2014-08-05 08:35:18

SynCardia Systems, Inc., now controls last key component in heart manufacturing. TUCSON, Ariz., Aug. 5, 2014 /PRNewswire/ -- SynCardia Systems, Inc. received approval July 2, 2014 from the United States Federal Drug Administration (FDA) for the SynCardia temporary Total Artificial Heart with SynHall(TM) valves, giving the company control over the last key component to manufacture the Total Artificial Heart. http://photos.prnewswire.com/prnvar/20140804/133128 FDA approval follows SynCardia's...

2014-08-04 23:09:30

On July 25, GoMacro informed that MacroBars "almond butter + carob", and "sunflower butter + chocolate" are recalled because they have the potential to be contaminated with Salmonella. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 04, 2014 AttorneyOne.com, a recognized authority on law, updates the website daily regarding all the latest information from...

2014-08-04 08:28:43

FREDERICK, Md., Aug. 4, 2014 /PRNewswire/ -- The following is a letter from the President of BioElectronics Corporation (OTC Pink: BIEL) to shareholders: Dear BIEL Shareholders: BioElectronics Corporation's mission is to change the way people heal and relieve their pain. As the chart below, that clearly demonstrates that, we have done exactly that. http://photos.prnewswire.com/prnvar/20140801/132705 Chronic pain sufferers in the United Kingdom said that ActiPatch reduced their pain by more...

2014-08-04 08:28:32

Significant company milestones include completion of the Phase 2 PUNCH(TM) CD clinical trial and FDA designation of RBX2660 as Orphan Drug and Fast Track ROSEVILLE, Minn., Aug 4, 2014 /PRNewswire/ -- Rebiotix Inc. announced this morning that it has raised a total of $25 million in Series B Funding. The total funds raised since inception by the clinical-stage biotechnology company founded in 2011 is $30 million. Rebiotix will use the additional funds to support pivotal clinical...

2014-08-01 23:06:59

On July 30, the FDA published that one lot of Lidocaine HCI Injection, USP, 2%, by Hospira is recalled due to visible particulates. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 01, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Lidocaine HCI Injection. The US FDA published on July 30, that...

2014-08-01 12:27:02

Persistent gender inequity at FDA has led to 26 approved drugs for men, ZERO for women WASHINGTON, Aug. 1, 2014 /PRNewswire-USNewswire/ -- In the latest call for gender equity in the approval of treatments for sexual dysfunction, more than 60 doctors and leading medical experts from across the country have penned an open letter questioning the Food and Drug Administration's (FDA) decision to approve 26 drugs marketed for the most common form of male sexual dysfunction compared with...

2014-08-01 12:26:51

Persistent gender inequity at FDA has led to 26 approved drugs for men, ZERO for women WASHINGTON, Aug. 1, 2014 /PRNewswire-USNewswire/ -- In the latest call for gender equity in the approval of treatments for sexual dysfunction, more than 60 doctors and leading medical experts from across the country have penned an open letter questioning the Food and Drug Administration's (FDA) decision to approve 26 drugs marketed for the most common form of male sexual dysfunction compared with...

2014-08-01 08:26:18

For U.S. Media Only RIDGEFIELD, Conn., Aug. 1, 2014 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Striverdi(®) Respimat(®) (olodaterol) Inhalation Spray 5 mcg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. STRIVERDI RESPIMAT is not indicated to treat acute...

2014-07-31 23:20:22

On July 24, Lion Pavilion LTD informed that Tasty Peach Slices is recalled because it contains undeclared sulfites. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. (PRWEB) July 31, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on peach slices. Lion Pavilion LTD informed on July 24, that it is recalling Tasty Peach Slices...

2014-07-31 23:18:36

The large number of FDA warning letters continually issued for improper equipment qualification is a clear sign that companies are still struggling to correctly implement this USP 1058 general chapter. During this webinar, Dr. Ludwig Huber, PhD will take attendees step-by-step through the complete qualification process and teach them how to create a bullet-proof master plan that will pass FDA scrutiny. Falls Church, VA (PRWEB) July 31, 2014 How to Implement USP 1058 for Lab Equipment...


Word of the Day
mallemaroking
  • Nautical, the visiting and carousing of sailors in the Greenland ships.
This word is apparently from a confusion of two similar Dutch words: 'mallemerok,' a foolish woman, and 'mallemok,' a name for some persons among the crew of a whaling vessel.