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EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
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Three decades of pharmaceutical excellence: CPhI Worldwide
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
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NDMA discovered in samples of ranitidine medicines
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
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FDA emphasises need for adverse event reporting of compounded drugs
The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
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Bacteriostatic Water recalled due to a potential lack of sterility assurance
Bacteriostatic Water is being recalled because of a lack of sterilisation confirmation for some vials.
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Global LC-MS market to exhibit CAGR of 6.9 percent
Research has found that the worldwide LC-MS market will be worth $2750 million by the end of the forecast period in 2024.
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CEO of Novartis pledges to speed data integrity disclosures
Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
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Federal judge enters consent decree against drug distributors
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
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EMA to review Picato after rise in skin cancer cases
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
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Korean pharma company alleged to have conducted trials on employees
Ahngook Pharmaceuticals reportedly held clinical trials on its employees without their consent, leading to the arrest of the company president.
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Pharma reputation worst among other industries in US
An annual report has found that the pharmaceutical sector is the lowest regarded industry among US citizens.
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Developments in stability testing and evaluation
The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.
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Allowable levels of excipients in drug products
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
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ICH Q10 knowledge management
The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to…
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Sandoz issues voluntary recall for medication bottles
The pharmaceutical company has announced a recall for certain prescription drug bottles which do not meet child-resistant regulations.
