Year: 2021
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Computer system validation
A computerized system can include hardware, software, its peripherals, interfaces, equipment, users, and operating procedures. Today, in the health products industry that encompasses pharmaceuticals, biologics, vaccines, biotechnology, natural health products, medical devices, cosmetics and allied industries, software and hardware components are used for the purposes of data processing, data storage, and process control. Computer system…
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Pharmacovigilance System Master File (PSMF)
The Pharmacovigilance System Master File (PSMF) is a document, designed to summarize the pharmacovigilance (PV) system of the marketing authorization holder (MAH). This document is named differently in many countries, namely, PvMF in India and in the EU, it is known as PSMF. Objective of PSMF: Describe the pharmacovigilance (PV) system Support/document PV system’s compliance…
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UK-MHRA approves Merck’s Oral COVID-19 Antiviral Medicine
Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, receives first authorization in the world with trade name of Lagevrio (molnupiravir), by MHRA. Lagevrio is not intended to be used as a substitute for vaccination against COVID-19 but for the treatment of Mild-to-Moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have…
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Summary of FDA new draft guidance on safety reporting obligations for investigators
Most of the information about the safety of a drug prior to marketing comes from clinical trials. Adverse event reports from investigators are therefore critically important, given that it is the investigators who observe subjects responses to an investigational drug. The investigator must immediately report to the sponsor any SAEs, regardless of whether the investigator…
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Expedited Reporting
An individual case safety report of one or more adverse events that must be submitted within a specified amount of time due to the severity of events, is Expedited reporting Worldwide regulatory authorities require expedited reporting of individual cases received by drug companies that meet specific criteria like validity, seriousness, expectedness of events and relation…
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FDA Update on cholesterol-lowering statins during pregnancy and breast-feeding
The U.S. Food and Drug Administration (FDA) is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. As per FDA, Patients should not breastfeed when taking a statin because the medicine may pass into breast milk…
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US-FDA – IND Safety Reporting requirements
IND Safety Reporting Summary: IND application sponsors are required to notify FDA in a written safety report of: any adverse experience associated with the use of the drug that is both serious and unexpected or any findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity,…
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Understanding Regulatory Adverse Event Reporting Requirements – US-FDA Post marketing
Post Marketing Safety Reports: The manufacturers must submit post-marketed safety reports to the FDA in electronic format for their medicinal products and vaccines. Types of Adverse event experiences: Serious and unexpected adverse experiences from all sources, whether domestic or foreign, must be submitted to the FDA. Possible sources include, for example, scientific literature, postmarketing studies,…
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TGA Safety alert – Novartis-Bio Somatropin Human Growth Hormone (HGH)
The Therapeutic Goods Administration (TGA), in conjunction with Sandoz Pty Ltd and Novartis Australia, has investigated reports of counterfeit Somatropin HGH vials in community circulation. From this investigation the TGA has established that Novartis-Bio Somatropin HGH (191 amino acid sequence rDNA origin for injection) 3.7mg per Vial (10x10IU Vials of Somatropin) as presented in the…
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Special Situations Reporting – Use of a medicinal product during pregnancy and breastfeeding
The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the foetus either before the placenta is fully developed or subsequently, if they can cross the placenta to at least some extent. Substances used for therapeutic purposes in the mother have the potential to reach the foetus with…