From their meeting in December, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the December CHMP meeting 2019”
Category: Product information
The latest updates on a variety of pharmaceutical products
The discovery of NDMA impurities in a common diabetes drug
Singapore’s Health Sciences Authority (HSA) has recalled three locally marketed metformin medicines after it was discovered that they contained N-nitrosodimethylamine (NDMA) impurities. Read more “The discovery of NDMA impurities in a common diabetes drug”
New “smart pill” technology shows 100% success rate
A new “smart pill” bottle which prompts patients to take their medications on time and notifies doctors when it has been dispensed, has shown 100% reliability in improving medication adherence. Read more “New “smart pill” technology shows 100% success rate”
Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have published a best practice guide for marketing authorisation applicants, covering multilingual packaging requirements for mutual recognition (MR) and decentralised procedure (DCP) products. Read more “Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?”
Highlights from the November CHMP meeting 2019
From their meeting in November, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the November CHMP meeting 2019”
How can the consistency in wording of therapeutic indications be improved?
The European Medicines Agency’s (EMA) human medicines committee (CHMP) have released a paper outlining key criteria for improving consistency when defining therapeutic indications in the product information of medicines. Read more “How can the consistency in wording of therapeutic indications be improved?”
Highlights from the October CHMP meeting 2019
From their meeting in October, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the October CHMP meeting 2019”
The Food and Drug Administration has finalised a guidance which will assist sponsors in designing and conducting non-clinical studies of investigational ERT products
Enzyme Replacement Therapy products are used to treat a wide range of metabolic disorders which have resulted from inherited defective genes (for example; Gaucher disease, Fabry disease or Pompe disease).
What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system
The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA). Read more “What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system”
Have you seen the FDA’s guidance on child-resistant packaging statements in drug product labelling?
This guidance released by the United States (US) Food and Drug Administration (FDA) is intended to assist firms who choose to display child-resistant packaging (CRP) statements on their product’s labelling. Read more “Have you seen the FDA’s guidance on child-resistant packaging statements in drug product labelling?”