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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

FDA Issues Draft Guidance on Management of Cybersecurity in Medical Devices

The New Guidance ... risk-based approach to the design and development of appropriate cybersecurity protections. The FDA wants manufacturers to design programs to follow their devices throughout the d... read more

Rare Disease Pre-IND Meetings: FDA Offers Draft Guidance

... in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Specifically, the guidance discusses issues commonly encountered in the early ... read more

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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 to bolster cybersecurity of medical devices

Cyber risks ... guidance involves having the FDA make changes to its internal processes to make sure it asks questions about medical device cybersecurity earlier in the device-approval process, and to ... read more

FDA Issues Final Guidance on Medical Device Benefit and Risk Analysis for 510(K)S

The FDA recently released a final ... Technological Characteristics.” The guidance is intended to help applicants demonstrate substantial equivalence and to provide guidance when the benefit-risk prof... read more

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

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

Health Canada Puts Brakes on SaMD Draft Guidance

The presentations during the advisory panel’s meeting discussed a range of issues related to the regulation of digital health technologies based on the risk-based SaMD definition ... the focus on the ... 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 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

FDA to bolster cybersecurity of medical devices

FDA officials welcomed the report, noting they were already following most of its guidance and going beyond ... such questions are asked uniformly when new device submissions are made. Many high- and ... read more

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