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Chinese SFDA Approves Helicon’s (ASX:HCG) ReCell(R) Concept And Kit - Skin Regeneration Concept And Device

Helicon Group Limited (ASX:HCG) is pleased to announce that earlier this month the Chinese State Food and Drug Administration (SFDA) granted approval for the skin regeneration concept and device, ReCell(R), for sale in China. The approval process for the product has been complicated and intensive due in part to the pioneering nature and complexity of the [...]

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AFederal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

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Researcher warns of brain cancer risk from cellphones

The warning is contrary to a lack of official concern by the U.S. Food and Drug Administration and numerous studies that have not found a link between cancer and cellphone use.

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Welcome to Thoreau-FDA.com… MHRA employees - are you watching?

Come on you MHRA employees and ex-employees - what are you waiting for? Welcome to Thoreau-FDA.com, a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful [...]

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Welcome Thoreau-FDA.com

Thoreau-FDA.com is composed of and/or descriptive of current and ex-US Food and Drug Administration (US FDA) staff who have succeeded, in resisting their upper management’s wrongful directives and requests that put public health at avoidable risk. When unchecked, these wrongful directives/requests cause drug review outcomes to be misrepresented as carefully considered objective "science based" assessments,...

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In passing…

Still under the weather, but I tend to think it’s because I haven’t been eating my jalepenos: The U.S. Food and Drug Administration said on Monday it found a jalapeno pepper contaminated with the strain of salmonella that has sickened more than 1,200 people and warned everyone across the United States to stop eating them. But the [...]

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FDA Launches Fellowship Program To Develop Pipeline Of Scientists, Other Professionals

The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. The FDA Commissioner’s Fellowship Program will provide participants with advanced training in the scientific analysis involved in the safety and regulatory decisions unique to the agency’s mission. “Attracting [...]...

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Topamax (topiramate) May Cause Birth Defects [PharmaGazette]

Only one month after Johnson & Johnson was required to put a black box warning on Regranex and a week after the U.S. Food and Drug Administration rejected a black box warning on epilepsy drugs, research has found that J&J's Topamax may increase the risk of birth defects. The study, a small one of 203 patients, found a 14-fold increase in the risk of birth defects in patients taking the epilepsy drug...

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House committee begins investigation of faulty FDA drug approvals

[JURIST] Two members of the US House of Representatives Committee on Energy and Commerce began an investigation Tuesday into whether the Food and Drug Administration (FDA) allowed the continued sale of certain drugs that agency officials knew had been manufactured and sold using faulty data. The investigation began after the US Attorney for the District of Maryland filed a motion with the district...

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FDA Chief Blasted for Deadly Dog Tests in Full-Page Washington Post Ad

PETA has taken out a full-page ad in the Tuesday, July 22, edition of The Washington Post, slamming Andrew Von Eschenbach, commissioner of the Food and Drug Administration (FDA). Displaying his photo next to the heading "Meet Andrew Von Eschenbach. On His Watch, the 'FDA' Stands for 'Federal Dog Abuse,'" the ad condemns the FDA for pushing cruel and outdated animal tests. The ad continues, "Help PETA...

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Texas-Based HEB Grocery Chain Voluntarily Recalls Jalapeno Products

The HEB grocery chain is removing from its shelves all fresh jalapenos, pico de gallo and other items prepared with raw jalapenos following the Food and Drug Administration's (FDA) warning that the peppers might be linked to salmonella. The voluntary recall by the Texas-based grocery store chain was ordered as a precaution after FDA officials found a strain of salmonella in a Mexican-grown jalapeno...

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Lawmakers probe FDA approval of Ranbaxy drugs

WASHINGTON (Reuters) - Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data.

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Mylan Announces Tentative Approval For Venlafaxine Hydrochloride Tablets

Mylan Laboratories Inc. (NYSE: MYL) announced that the U.S. Food and Drug Administration have granted tentative esteem all for Mylan Pharmaceuticals Inc.'s Abb revia ted New Drug Application for Venlafaxine Hydrochloride Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base). Ranitidine Syrup, the generic alike of GlaxoSmithKline's Zantac(R) Syrup, will be untaken in the...

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NexMed erectile dysfunction drug gets rejected

NexMed Inc. said Tuesday the Food and Drug Administration rejected its application for an experimental topical treatment for erectile dysfunction. The rejection in the form of a “nonapprovable letter” referred to potential issues in a study performed on mice to test whether the experimental product is carcinogenic. That study was completed in 2002 and the company [...]

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[khabor.com] Wireless Device Approved for DiabeticsWireless Device Approved for Dia betics

Wireless Device Approved for DiabeticsWireless Device Approved for Diabetics July 1 (HealthDay News) -- The OneTouch Ping glucose management meter, which communicates without wires to a pump that delivers insulin to people with diabetes , has been approved by the U.S. Food and Drug Administration, maker Animas Corp. said Tuesday. The system allows users to receive an insulin dose -- based on the meter...