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FDA Approvals: September 2022 Recap

Digital Pharmacist

Date of Approval: 9/30/2022. Common adverse effects include musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, and abdominal pain , among others. . Date of Approval: 9/29/2022. Common adverse effects noted include diarrhea, abdominal pain, nausea, and upper respiratory tract infection. .

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FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling

The FDA Law Blog

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

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FDA approves first capsid inhibitor for HIV

European Pharmaceutical Review

The second group received open-label Sunlenca. The most common adverse reactions with Sunlenca were injection site reactions (swelling, pain or redness) and nausea. As part of the trial, patients were enrolled into one of two study groups. After 52 weeks, 83 percent of participants continued to have HIV RNA suppression.

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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). References.

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2022 ISPE China Pharmaceutical Supply Chain Summit

ISPE

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.

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Shanghai ISPE Pharmaceutical Information Company holds 2022 China Pharmaceutical Supply Chain Summit

ISPE

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. Shi Yun, QA Manager of Restone Biomedicine Co.,

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Mounjaro interactions to avoid

The Checkup by Singlecare

Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Mounjaro (tirzepatide) is gaining popularity as a treatment for Type 2 diabetes mellitus and off-label for weight management. The ones that it does have are important, though.