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iPhone urinalysis app draws scrutiny from FDA

Biosense Technologies' uChek system turns Apple's iPhone into a capable urinalysis device, and now the Food and Drug Administration is saying that it may need to clear the medical app lest developers risk violating federal law.

FDA ordered to set timing for food safety rules by June 10

The Food and Drug Administration and the Center for Food Safety have until June 10 to agree on the timing for release of pending food safety rules related to the 2011 Food Safety Modernization Act.

iPhone Urinalysis App Draws U.S. Government Scrutiny

The U.S. Food and Drug Administration has sent a letter to BioSense Technologies over its iPhone uChek urinalysis system, asking why its medical app hasn't been cleared by the agency. The app is one of the first that turns the iPhone...Show More Summary

FDA begins cracking down on medical diagnosis apps starting with ‘uChek’ iPhone urinalysis app

Bloomberg reports the U.S. Food and Drug Administration is launching a first of its kind inquiry into medical diagnosis apps starting with the ‘uChek’ urine analysis app from Biosense Technologies. The free app, which is currently still on the App Store, requires users to purchase a kit containing urine test strips that can be visually […]

Unclear Future for Merck's Insomnia Drug

Yesterday, the Food and Drug Administration's (FDA) advisory committee met to discuss Merck's  experimental insomnia drug Suvorexant. While the committee did agree that the drug was effective at lower doses, there were some concerns over the side-effects associated with the medication at higher doses. Show More Summary

FDA says it needs more money for FSMA

The Food and Drug Administration reported on its progress with food safety initiatives May 23, stopping short of saying many requirements of the Food Safety Modernization Act are unfunded mandates for the agency and its state and local counterparts. Show More Summary

Obama's Empty Rhetoric

2 days agoNews : Reason

Like the "War on Drugs," a rhetorical phrase that the Obama administration has rejected even while continuing o wage the policy it describes, many ongoing activities of the government he presides over came under verbal attack from President Barack...Show More Summary

Drug reverses Alzheimer's disease deficits in mice

An anti-cancer drug reverses memory deficits in an Alzheimer's disease mouse model, new research shows. The article reviewed previously published findings on the drug bexarotene, approved by the US Food and Drug Administration for use in cutaneous T cell lymphoma.

National Briefing | Washington: Senate Committee Approves Bill on Compounding

2 days agoHealth : NYT: Health

A Senate committee approved a bill on Wednesday that would give the Food and Drug Administration greater authority over compounding pharmacies.

Biogen Idec Submits Application To FDA For Approval Of Plegridy™ (Peginterferon Beta-1a) In Multiple Sclerosis

EMA Submission Planned in the Coming Weeks Biogen Idec (NASDAQ: BIIB) has announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY™ (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS). Show More Summary

US Offers Russia Closer Counter-Narcotics Cooperation

The United States’ Drug Enforcement Administration (DEA) has offered Russia’s Interior Ministry closer cooperation abroad, its head said during a meeting with Russia’s interior minister on Wednesday.

Merck's Novel Immunotherapy Drug Receives 'Breakthrough Therapy Designation'

By The Swiss Trader: In April the global health care giant Merck & Co. (MRK), received "breakthrough therapy designation" from the U.S. Food and Drug Administration (FDA) for its investigational antibody therapy, lambrolizumab, a drug that treats patients with advanced melanoma. Show More Summary

Court Extends Deadline for FSMA Rules

The Center for Food Safety’s tug-of-war with the U.S. Food and Drug Administration over the agency’s delayed food safety rules continued last week as a judge ruled that FDA had more time to come up with a schedule for releasing the outstanding rules. In a ruling May 17, Judge Phyllis Hamilton of the Oakland U.S.... Continue Reading

Find the Flaw

(May 21, 2013 05:57 PM, by David Henderson) Here is a passage from one of my favorite economics textbooks: When physicians must be licensed and new drugs approved by the Food and Drug Administration (FDA) before they can be marketed, buyers are spared the cost of evaluating goods... (0 COMMENTS)

Hobby Lobby Battles Obama Admin in Court Thursday Over HHS Mandate

Christian crafts store Hobby Lobby will battle the Obama administration in court Thursday over whether or not the HHS Department can force it to comply with the mandate that compels it to pay for birth control and drugs that may cause abortions. The Becket Fund for Religious Liberty will represent Hobby Lobby Stores before the [...]

Comment Period on Labeled Sweeteners in Milk Ends Tonight

The public comment period for new labeling rules on flavored milk an 17 other dairy products will end May 21 at 11:59 p.m. eastern time, according to the U.S. Food and Drug Administration proposal posted on the Federal Register Feb. 20. If implemented, the rules would change the “standard of identity” for milk to allow certain... Continue Reading

Patent-Protected Technology Ended Up on FDA Website, Companies Charge

Two small Maryland companies have launched a campaign to publicize their allegations that the U.S. Food and Drug Administration (FDA) stole their patented technology. The two small businesses, FoodQuestTQ, LLC and Projectioneering LLC...Show More Summary

Will the FDA Approve Merck's Insomnia Drug?

The advisory committee meeting is this Wednesday, but investors will have to wait until the summer to discover the Food and Drug Administration's decision.

Will the FDA Approve Merck's Insomnia Drug?

It's no secret that decisions from the Food and Drug Administration are incredibly hard for investors to predict. Take for instance the FDA's rejection of Novo Nordisk's insulin drugs Tresiba and Ryzodeg in February. The products got...Show More Summary

FDA offers web seminar on food defense planning

A May 22 web seminar from the Food and Drug Administration will give food industry professionals how-to direction on building food defense plans for their facilities.

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