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Latest Federal Food, Drug, and Cosmetic Act Stories

2014-06-10 08:31:44

MOMENCE, Ill., June 10, 2014 /PRNewswire/ -- In a recent comment on the FDA's Guidance for Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application (IND) (79 Fed. Reg. 7204. Docket FDA-2010-D-0503), FutureCeuticals expressed its strong support for gold-standard, peer-reviewed clinical research on food and dietary ingredients and urged the FDA to properly supervise any clinical research on food or dietary ingredients under the purview...

2014-06-03 23:10:00

Firm's M1 Capnography Mask obtains US market authorization with support from Emergo Group. Seattle, WA (PRWEB) June 03, 2014 Seattle based Monitor Mask Inc., has obtained US Food and Drug Administration 510(k) premarket notification clearance for the M1 Capnography Mask. The M1 Capnography Mask is a disposable oxygen face mask designed to monitor patient breathing by directly interfacing with a sidestream capnograph. Capnography, or exhaled CO2 monitoring, is increasingly recognized...

2014-05-27 23:01:09

Medtronic is attempting to rely on the legal concept of preemption, which has been used by a number of medical device makers when arguing liability lawsuits filed over U.S. Food and Drug Administration- (FDA) approved devices. Port Washington, NY (PRWEB) May 27, 2014 A key issue in this case involves “failure-to-warn” claims that may be preempted by federal oversight of high-risk medical devices. Following the high court’s October request that it provide an opinion in a dispute...

2014-02-22 00:20:49

KENNEWICK, Wash., Feb. 21, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCBB: ADMD), a company engaged in the development, production and distribution of medical isotopes focused on yttrium-90 brachytherapy devices, today announced that it has received a response from the FDA to its pre-market notification to the FDA pursuant to Section 510(k) of the U.S. Food, Drug and Cosmetic Act for its Yttrium-90 (Y-90) RadioGel(tm) patented brachytherapy cancer product....

2014-01-31 08:25:48

ATLANTA, Jan. 31, 2014 /PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, recently announced the approval and launch of Loutrex Topical Cream following a successful 510(k)(1 )notification with the Food and Drug Administration (FDA), which determined that Acella's 510(k) submission was equivalent to another legally U.S.-marketed device and at least as safe and effective as the predicate. The approved 510(k) (Loutrex) is indicated to manage and relieve...

2014-01-27 08:28:28

"Outsourcing Facility" recognizes importance of protecting hospitals and healthcare providers as well as patients LAKE FOREST, Ill., Jan. 27, 2014 /PRNewswire/ -- In the two months since the Drug Quality and Security Act (DQSA) was signed into law, 11 compounders have registered a total of 14 facilities as "Outsourcing Facilities" per the U.S. Food and Drug Administration's (FDA's) Registered Outsourcing Facilities Web page, dated 1/17/14. This includes PharMEDium Healthcare...

FDA Regulatory Process Variable
2014-01-22 09:31:53

Rebekah Eliason for redOrbit.com – Your Universe Online According to a recent study, the approval of drugs by the Food and Drug Administration (FDA) is based on widely varying clinical trials between 2005 and 2012. The background from the article states that “FDA review of new drug applications is guided by the Federal Food, Drug, and Cosmetic Act, which requires 'adequate and well controlled investigations' to determine efficacy. Many patients and physicians assume that the safety...

2014-01-20 12:25:45

New Category Subject to More Rigorous Inspections and Quality Standards TEMPLE, Texas, Jan, 20, 2014 /PRNewswire/ -- Unique Pharmaceuticals, Ltd., (UPI), today announced it has voluntarily registered with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility following guidance from the recently enacted Drug Quality and Security Act. "At Unique Pharmaceuticals we have always been and will remain firmly committed to the quality and safety of our...

2013-07-16 23:26:19

Revolutionary Science, the manufacturer of the FDA approved Saniclave 200, weighs In on the dangers of using a non-FDA approved autoclave for human use. Minneapolis, MN (PRWEB) July 16, 2013 Dental offices, medical clinics and even tattoo and nail salons are being required to use FDA cleared (approved) steam autoclaves, like the Tuttnauer Elara or the Saniclave 200 (retailing currently at about $999). Steam autoclaves such as these are highly regulated and have long been proven to be the...

2013-05-04 23:01:24

“Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market” is the new market research report added to ReportsnReports.com store. Dallas, Texas (PRWEB) May 04, 2013 Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices. The...


Word of the Day
grass-comber
  • A landsman who is making his first voyage at sea; a novice who enters naval service from rural life.
According to the OED, a grass-comber is also 'a sailor's term for one who has been a farm-labourer.'