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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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STAT+: A ‘disaster’, or a ‘clear path’ forward?: New FDA guidance on AI in medicine sparks strong reactions

STAT

One medical device lawyer wrote that the document “violates” the 21st Century Cures Act passed by Congress in 2016 to exempt certain software products from regulatory review. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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How to get Ozempic prescribed for weight loss

The Checkup by Singlecare

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

The FDA Law Blog

As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. FDA defines a Home Use Device as “a medical device intended for users in any environment outside of a professional healthcare facility.

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Water stagnation: Preventing contamination of water systems in vacated buildings

Pharmaceutical Technology

From hospitals and hotels to offices and gyms, water stagnation must be mitigated wherever water may be directly consumed or used for washing. Preventing water stagnation in hospitals. For hospitals busy during the pandemic, it might have been assumed that water stagnation would not be a risk. They are available with 0.2-micron

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How common are changes to the primary endpoint in oncology RCTs?

Hospital Pharmacy Europe

A lack of transparency The importance of setting the primary outcome prior to commencing a study and not deviating from the original protocol, was first highlighted in 1990 by Jay Siegel , a physician and research scientist working for the FDA in the US. appeared first on Hospital Pharmacy Europe.