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GeneSight® Mental Health Monitor Results

Myriad Genetics

The majority of these patients (54%) agree that genetic testing for mental health medications (known as pharmacogenomic or PGx testing) could reduce these concerns. The majority of these patients (54%) agree that genetic testing for mental health medications (known as pharmacogenomic or PGx testing) could reduce these concerns.

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What to know about High Blood Pressure (Hypertension)

Georgetown Pediatrics & Family Medicine

Depending on your personal medical history and open discussion with your physician, this will guide your treatment plan. The Joint National Committee 2003 defines hypertension as systolic of 140 mmHg and higher or diastolic 90 mmHg and higher. At that time, you may need to start to incorporate blood pressure medications.

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Transition Plans for Covid-19 Products are Amongst CDRH FY2023 Priorities

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ).

Medical 52
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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

Importantly though, the Policy Statement does not provide any insight into the types of listings that do not meet the statutory criteria and thus would be considered anticompetitive. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

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Not An April Fool’s Joke: California BOP Establishes Loss Reporting Thresholds

FDA Law Blog

Owners must report the following dosage units meeting or exceeding these thresholds: Tablets, capsules or other medication-99 dosage units; Single-dose injectables, lozenges, films such as oral, buccal and sublingual, suppositories or patches-10 dosage units; and. 40,576, 40,578 (July 8, 2003).

IT 52
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Lead, follow or get out of the way

Physician's Practice

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt.

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The Supremes Give the FTC “Nothing but Heartaches”: Court Unanimously Rules No Restitution in Injunction Cases, and How Will This Ruling Impact FDA?

FDA Law Blog

The Court also looked at the structure of the FTC Act beyond §13(b) to §5(l) and §19 which provide for the imposition of limited monetary penalties and awards of monetary relief where the FTC has already engaged in administrative proceedings. 129 (2003). FDA’s response to our 2003 article, authored by Eric M. 169 (2003).