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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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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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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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Why is microbiological testing in medical device manufacturing important?

European Pharmaceutical Review

This microbial contamination can lead to a range of adverse events, such as infections, adverse reactions, or device failures, which can compromise patient safety and health outcomes. Rapid microbiology testing market growth expected 2022 to 2027 The post Why is microbiological testing in medical device manufacturing important?

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

ISPE

After nearly 4 years of polishing, China GMP2020 Edition Addendum -IMP was officially implemented on 27 May 2022. Wang Fang min, Chairman of Project and Alliance Management, Shanghai Pharmaceutical and Medical Device Adverse Reaction Monitoring Center;Ms. Lynn Wang, Head of Project and Alliance Management of Wuxi Bio;Ms.

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FDA approves first capsid inhibitor for HIV

European Pharmaceutical Review

The most common adverse reactions with Sunlenca were injection site reactions (swelling, pain or redness) and nausea. In August 2022, the European Commission (EC) granted marketing authorisation for use of Sunlenca ® (lenacapavir) injection and tablets in adults with multi-drug resistant HIV infection.

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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

He highlighted research by the Association of the British Pharmaceutical Industry (ABPI) from 2022, which found that between 2018 and 2020, “the median time between application for regulatory approval and delivery of a first dose to a participant in a trial increased by almost a month.”