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FDA Approvals: September 2022 Recap

Digital Pharmacist

CDER relies on its understanding of science and regulatory procedures to support and provide advice to pharmaceutical companies in testing and manufacturing, to then bring these new therapies to the market to aid patients and their health. The FDA granted the approval of Relyvrio to Amylyx Pharmaceuticals Inc.

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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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When is the best time to inject Ozempic?

The Checkup by Singlecare

Ozempic is one of three medications approved by the Food and Drug Administration (FDA) with the active ingredient semaglutide. Currently, Ozempic is FDA-approved for adults with Type 2 diabetes. Ozempic is made by the pharmaceutical company Novo Nordisk. Healthcare professionals typically prescribe an initial dose of 0.25

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Is Chantix Safe Again After the Nationwide Recall?

BuzzRx

In July 2021, the pharmaceutical company Pfizer issued a voluntary nationwide recall of Chantix (varenicline) tablets as a precautionary measure; this is due to the evidence of higher levels of nitrosamines in Chantix than what’s considered acceptable by the U.S. What adverse reactions can the anti-smoking drug Chantix cause?

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Drug Discard Date Creates Discord

The People's Pharmacy

The parties that benefit are the pharmaceutical companies and the pharmacies. The losers are patients, insurance companies and the country as a whole for wasting money on unneeded things. If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B.

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Flomax generic availability, cost, and dosage

The Checkup by Singlecare

With its FDA approval in 1997, Flomax has become a widely prescribed medication in the United States, particularly for older men more susceptible to BPH. Flomax is currently FDA-approved to treat the symptoms of BPH in men. What are the off-label uses for Flomax? However, some off-label Flomax uses may help relieve other conditions.

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Decentralized Clinical Trials: The Future of Clinical Research

Roots Analysis

Such trials make use of software applications, monitoring devices and online social media engagement platforms to conduct the complete clinical trial process, including recruitment , patient engagement, counseling, informed consent, electronic data capture, measuring clinical endpoints and adverse reactions, as per the patients’ comfort.