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FDA To Issue New Guidance On Lasik Risks - Latest News

FDA to issue new guidance on Lasik risks

The FDA plans to issue new guidance for the potential risks of Lasik eye surgery after a New York Times report showed that some patients experienced significant side effects. More than 190 million Ame... read more

F.D.A. Is Urged to Issue More Alerts About Drug Risks

The Food and Drug Administration’s efforts to issue “safety signals” when it is alerted to potential health risks of prescription drugs isn’t working well to notify the public or guide doctors to alte... read more

FDA Statement in Response to 'GMA's' Story on LASIK Eye Surgery

This year, the FDA issued a letter to LASIK providers outlining issues ... risks when used as intended in accordance with the approved indications and directions for use. In its consideration of LASIK ... read more

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Genomic Medicine: Is The Platform The FDA Product?

The key to these revisions may be tied to their belief that the use of novel platforms for gene therapy flips the risk profile from ... about the regulatory issues with these. The FDA intends to relea... read more

US FDA issues draft rules on labels & design to minimize medication error; Indian pharma appreciates norms

The guidance covers prescription drugs marketed under an approved new ... (OTC) drug products. This is the second in a series of three guidance documents that the FDA is issuing to help minimize medic... read more

Failed Lasik surgery is rare, but these are the potential risks

Lasik isn’t the silver bullet in perfect vision. Some patients still have to use reading glasses after the surgery, Lazzaro says. And about 45 percent of the patients in the FDA trial said they had a ... read more

Thinking About Lasik? The Risks Are Painfully Real

(Newser) – The promise of Lasik is it may offer an end to contacts and glasses; the reality is that it could lead to problems that may leave you longing for the old contacts and glasses. The New ... F... read more

FDA speedy process on devices worries ex-regulators

Under Shuren, annual new device approvals have more than tripled, while warnings to device manufacturers about product safety and quality issues ... "This guidance is basically a 'come hither' to indu... read more

Judge orders FDA to speed up graphic warnings requirements for cigarettes

Federal authorities cannot continue delaying guidance ... Drug Administration (FDA) in 2016, asking that warnings be implemented. “Studies around the world have shown that graphic warnings are most ef... read more

SteadyMed Receives Refusal to File Letter from FDA for Trevyent® New Drug Application

The Company will provide further guidance after the anticipated meeting with FDA. “We believe that the issues raised in the letter from FDA ... company's intentions to meet with the FDA and re-submit ... read more

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