Bill of Health

FEBRUARY 8, 2022

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. million children have tested positive for COVID since the pandemic, over 3.5

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Natalia Mazina

AUGUST 16, 2022

Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid.

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COVID-19 Informed Consent FDA Licensing 98

Bill of Health

JANUARY 24, 2022

Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set. The CDC, through its vaccine provider agreements, prevents physicians and parents from pursuing off-label use of COVID-19 vaccinations in young children.

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Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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Natalia Mazina

SEPTEMBER 20, 2021

This month, the American Medical Association, American Pharmacist Association, and American Society of Health-System Pharmacists issued a joint release urging prescribers and pharmacists to stop ordering, prescribing, and dispensing ivermectin to prevent or treat Covid-19 outside of clinical trials.

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COVID-19 FDA Informed Consent Doctors 85

HIT Consultant

NOVEMBER 17, 2021

As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Further underscoring this trend, 93% of sites also reported that they would allow sponsors or CROs to conduct remote monitoring, compared to 74% pre-COVID.

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COVID-19 Pharmaceutical Industry Informed Consent Compliance 97

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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