The United States (US) Food and Drug Administration (FDA) have finalised their guidance on the requirements and recommendations for submissions of promotional materials for human prescription drugs and biological products. The FDA stated that they received and considered multiple comments on the need to provide clarity on submission expectations and the technical features of electronic submissions. Read more “FDA releases final guidance on advertising and promotional material submissions”
Category: Medicinal product
Health Canada outlines when off-label use is not considered investigational in a clinical trial
Health Canada have issued a notice which outlines the circumstances in which the off-label use of an authorised drug in a clinical trial would not be considered investigational. The notice went into effect on 5th June 2019, and Health Canada have stated that the notice will “serve as interim interpretive guidance until amendments can be made to the Food and Drug Regulations.” Read more “Health Canada outlines when off-label use is not considered investigational in a clinical trial”
MHRA opens consultation on the application of analytical quality by design principles to pharmacopoeial standards for medicines
The Medicines and Healthcare Products Regulatory Agency (MHRA) have opened a consultation on their plans to apply analytical quality by design (AQbD) principles to pharmacopoeial standards for medicines. The public consultation closes on 31st August 2019 and the MHRA hopes to learn about the opportunities and challenges relating to pharmaceutical quality, and how AQbD concepts are used by drug manufacturers. Read more “MHRA opens consultation on the application of analytical quality by design principles to pharmacopoeial standards for medicines”
Highlights from the May CHMP meeting
From their meeting in May, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for four medicines for approval. Read more “Highlights from the May CHMP meeting”
EMA encourages early engagement with medicine developers to help fight antimicrobial resistance
The European Medicines Agency (EMA) have opened up an early dialogue, which is available through its Innovation Task Force (ITF), to all medicine developers working on therapeutic approaches for the treatment or prevention of bacterial and fungal infections. Read more “EMA encourages early engagement with medicine developers to help fight antimicrobial resistance”
Highlights from the April CHMP meeting
From their meeting in April, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for thirteen medicines for approval. Read more “Highlights from the April CHMP meeting”
MHRA updates its “final determinations on borderline products”
MHRA has published an updated list of final determinations issued by the Borderline division within the agency. Details of the product names, the names of the companies to whom the determination notices were issued and brief details of the reasons for the determination are provided. Read more “MHRA updates its “final determinations on borderline products””
Swissmedic updates guidance on orphan drugs and paediatric investigation plans
The Swiss Agency for Therapeutic Products (Swissmedic) has updated their guidance on orphan drugs and paediatric investigation plans (PIPs). Topics addressed include orphan drug fees and the documentation companies need to supply to support European and American PIPs. Read more “Swissmedic updates guidance on orphan drugs and paediatric investigation plans”
Highlights from the February CHMP meeting
From their meeting in February, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced the recommendations of eight medicines for approval, including two orphan medicines. For three out of the eight new medicines, the CHMP recommended a conditional marketing authorisation. Read more “Highlights from the February CHMP meeting”
Opioid Expert Working Group meets at MHRA
At the Medicines and Healthcare products Regulatory Agency (MHRA), an Expert Working Group (EWG) of the United Kingdom’s (UK’s) Commission on Human Medicines (CHM) met to begin reviewing the benefits and risks of opioid medicines, which includes dependence and addiction. Read more “Opioid Expert Working Group meets at MHRA”