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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. That can be incredibly informative. Everybody ages.

IT 120
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It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law

FDA alleged that because the TV ads contained representations or suggestions relating to Emgality’s indication for use, they were required to include risk information as well adequate provision for the dissemination of the PI or a brief summary as required by 21 C.F.R.

IT 40
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Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

FDA Law

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). PCR) test is considered the gold standard for actual diagnosis. 2 infection.

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New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction. Emphasis added.)

Medical 53
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CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.