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iPDF: Complete solution for your sterility testing workflow
Extensive portfolio of quality control solutions. Full regulatory compliance (USP, EP, JP Pharmacopoeias) of your sterility testing workflow.
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news
FDA and FTC issue warning letters to companies selling fraudulent COVID-19 products
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
article
Exploring data integrity guideline changes moving into 2020
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
news
FDA approves Isturisa (osilodrostat) treatment for Cushing’s disease
The FDA has approved Isturisa for Cushing’s disease treatment after it demonstrated significant efficacy in clinical trials.
news
3.5 million unlicensed erection pills seized in the UK in 2019
The UK MHRA has announced that the approximately 3.5 million unlicensed erection pills seized last year are worth more than £10 million.
news
FDA approves DURYSTA™ (bimatoprost implant) New Drug Application
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
news
Emerade 150 micrograms auto-injectors recalled in UK
The UK MHRA has announced that Emerade 150 micrograms solution for injection is being recalled due to an error in one component of the auto-injector.
news
Online pharmacy finds high levels of NDMA in metformin
Tests conducted by an online pharmacy has revealed high levels of NMDA in the diabetes drug metformin, prompting the company to press for a recall.
news
CMA levels over £3.4m in fines for competition law breaches
The UK’s Competition and Markets Authority (CMA) has fined four companies in because of anti-competitive practices in the supply of nortriptyline.
news
Thin film platform to preserve vaccines at room temperature developed
A new vaccine formulation has been created by researchers, which uses a peelable film during drying to preserve the medicine.
news
EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
news
EMA announces update on nitrosamine impurities in medicines
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
news
Raman spectroscopy and mass spectrometry to be used in study of topically applied drugs
The US FDA will fund a research project using Raman spectroscopy and mass spectrometry to study drug delivery via the skin.
video
Video: Reduce the risks when piercing your sample
Safer sterility testing workflow. Reduce the risks when piercing product small sample packaging.
news
Orphan Drug Designations are declining, says market analysis
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.
