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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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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes. In another update, the recent draft guidance added “entities reviewing safety data” and adaptation committees.

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Does Aetna cover Contrave?

The Checkup by Singlecare

Formulary Every insurance plan has a long document that shows how it covers each prescription medicine, called a formulary. Aetna’s many formulary documents show that Contrave (when it’s listed) often falls under non-preferred brands. Some plans will, in fact, provide coverage. It’s all based on a few different variables.

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Does phentermine help with ADHD?

The Checkup by Singlecare

Food and Drug Administration ( FDA ) as a weight loss medication. As of now, phentermine is not FDA-approved for ADHD, and the evidence of its effectiveness is scarce. Phentermine is an old psychotropic medication that is indicated by the FDA for the short-term treatment of weight loss,” she says. “It

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Qulipta vs. Nurtec: Differences, similarities & side effects

The Checkup by Singlecare

While both Qulipta and Nurtec have similar mechanisms of action and are approved by the Food and Drug Administration (FDA) for migraine treatment , they have distinct applications: Qulipta is mainly used for the prevention of episodic migraines, whereas Nurtec can both prevent and treat acute migraine episodes.

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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. Unicycive plans to resolve FDA concerns by utilizing a second manufacturing vendor with a successful regulatory history to address manufacturing-related issues.

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