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FDA To Issue New Guidance On Lasik Risks - Latest News

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

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

FDA: Essure sterilization device can't be sold without 'unique' warnings to patients

“This is a unique restriction, and it will help resolve the issue we brought up with Commissioner Gottlieb, that almost 95 percent of women implanted after the FDA’s guidance was issued were not getti... read more

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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

After French drug trial tragedy, European Union issues new rules to protect study volunteers

The European Medicines Agency (EMA) has issued new ... ethical guidance on weighing the benefits against the risks before a trial starts, he adds. Some researchers criticized the Bial trial because th... read more

FDA sends record low number of warnings to drugmakers found lying in ads

The FDA's Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren't being scammed by false assertions. The pharmaceutical industry spent a vast $6.4 bill... read more

Congress passes 'right to try' experimental drug bill, allowing the critically ill to bypass FDA

The FDA would be largely left out of the equation under the new legislation and would not oversee ... are best made by the patients with the support and guidance of their treating physicians." The iss... read more

Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression

Sage Therapeutics (SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the Company has submitted ... read more

What to Know About LASIK Surgery

During LASIK surgery, patients stay awake for the procedure but are given numbing eye drops. (BSIP/UIG via Getty Images) When one of Kristina Alton's contact lenses fell out at her office in New York ... read more

Lasik surgery falling out of favor with patients

The FDA is taking steps to address the complication-rate issue with ... months post-Lasik (without visual correction), according to Eydelman's presentation. Up to 45 percent of patients who had no vis... read more

Crispr Therapeutics: Beware Of Articles Minimizing The Clinical Hold Risk

That possibility seems quite realistic given the process leading up to the IND filing which should have vetted any potential issues prior to submission. Graphic: Regulatory Guidance ... (FDA) has plac... read more

ICON Issues Financial Guidance for Full Year 2018

ICON plc (ICLR), a global provider of drug ... events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, bu... read more

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