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The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
Amid the disruptions due to COVID-19, companies providing sterile and antiviral packaging solutions look forward to opportunities arising from the concern over viral exposure itself. Regulatory compliance will play a significant role in the rapidly shifting risk terrain.
The problem of children accessing medication at home is growing and the UK’s National Health Service (NHS) claims the most common form of poisoning1 in the UK is from medication, with children under five being most at risk. While parents have a role to play in the home by keeping…
A new document has been released by the British Plastics Federation to help the pharmaceutical industry and other sectors understand how recycled plastic can be used in packaging.
Included in this in-depth focus are articles examining the importance of child-resistant medicinal packaging and analysing whether continuous processing is the future for pharma.
This issue focuses on the regulatory challenges associated with increased ventilator demand during COVID-19, as well as articles investigating the use of LC-MS for protein characterisation, improving efficiency with continuous processing and the risks posed by cleanroom contaminants. Other features discuss the continual evolution of solid dosage forms and the…
Biologics continue to be a major modality in the pharmaceutical pipeline. New and unique LC-MS tools will become available for use from discovery through QC.
Teva has informed the MHRA that the GTIN number found on a batch of levofloxacin tablets is incorrect, prompting the Medicines Defect Information alert.
The FDA has announced that Dr Reddy's is recalling Phytonadione injectable emulsion because of complaints due to ampules breaking and shattering.
A barcode for paracetamol 250mg/5ml oral suspension displays the wrong strength when scanned, prompting the MHRA to announce the defect information.
A private-public consortium to develop pre-filled syringe packaging has been backed by Jefferies, including a seed capital commitment of at least $10 million.
The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.
Safety updates to labels of SGLT2 inhibitors will recommend temporary discontinuation of these medications before scheduled surgery, says the FDA.
