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The Future Of Vision And Eye Care

The Medical Futurist

However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. Are 3D printed and digital contact lenses the future?

Diabetes 105
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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18.

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(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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Pregnancy outcomes and complications in refugees and other newcomers at a Family Medicine practice in Philadelphia, PA [Women's health]

Annals of Family Medicine

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

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Time for Geriatric Assessments in Cancer Care: William Dale, Mazie Tsang, and John Simmons

GeriPal

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. Or electronically, to fill out, right? Do you worry about that?

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DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.