The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement. Read more “The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications”
Category: Medicinal product
Drug Shortages: What are the Root Causes and Potential Solutions?
A new report on the underlying factors responsible for drug shortages, and the potential solutions, has been published by a United States (US) Food and Drug Administration (FDA) task force. Read more “Drug Shortages: What are the Root Causes and Potential Solutions?”
MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit
In the event of a no-deal Brexit, reference medicinal products (RMP) for new generic medicines or abridged marketing authorisation applications will be required to comply with the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs). Comparator products (CP) used in these applications will need to be representative of the RMP. Read more “MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit”
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”
Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?
The Medicines and Healthcare Regulatory Agency (MHRA) have released guidance summarising their approach and actions to be taken by businesses supplying the United Kingdom (UK) with medicines from the European Union (EU), Iceland, Lichtenstein or Norway. Read more “Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?”
Highlights from the September CHMP meeting 2019
From their meeting in September, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the September CHMP meeting 2019”
EMA to provide new guidance on avoiding nitrosamine impurities in human medicines
After various animal studies were conducted, nitrosamines have been classified as “probable human carcinogens”. Read more “EMA to provide new guidance on avoiding nitrosamine impurities in human medicines”
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?”
Highlights from the July CHMP meeting 2019
From their meeting in July, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the July CHMP meeting 2019”