The US Food and Drug Administration (FDA) has published draft guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). Read more “FDA publishes draft guidance on CMC changes to a biologics license application”
Year: 2017
EMA expects Pharmacovigilance fees to rise in mid-January 2018
The European Medicines Agency expects adjusted fees for pharmacovigilance applications to come into effect in mid-January 2018. Read more “EMA expects Pharmacovigilance fees to rise in mid-January 2018”
FDA releases draft guidance on investigational IVDs used in clinical investigations of therapeutic products
The US Food and Drug Administration (FDA) has released guidance that discusses how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study. Read more “FDA releases draft guidance on investigational IVDs used in clinical investigations of therapeutic products”
FDA releases draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease
Draft guidance released by the US Food and Drug Administration (FDA) aims to support the development of treatments that focus on underlying genetic mutations that cause or contribute to disease. Read more “FDA releases draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease”
FDA releases draft guidance on information requests and discipline review letters
The US Food and Drug Administration (FDA) has released draft guidance which establishes a new type of letter the agency sends to generic drug manufacturers to provide applicants with initial thoughts on possible deficiencies of an abbreviated new drug application (ANDA). The FDA will issue discipline review letters (DLRs) and information requests (IRs) to attain further information or clarification to ensure completion of a discipline review. Read more “FDA releases draft guidance on information requests and discipline review letters”
HPRA Ireland launches national pilot project regarding clinical trials regulation
The Health Products Regulatory Authority (HPRA) Ireland has published a guide to a national pilot project to facilitate preparation for the implementation of the new clinical trial regulation (Regulation (EU) No. 536/2014). Sponsors are invited to participate in the project which will run until the implementation of the Regulation. Read more “HPRA Ireland launches national pilot project regarding clinical trials regulation”
Highlights from the December CHMP meeting
From their meeting in December, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the December CHMP meeting”
FDA releases draft guidance on the least burdensome approach to regulating devices
The US Food and Drug Administration (FDA) have published draft guidance detailing updates to its least burdensome approach to regulating devices. By consolidating regulatory processes and removing or reducing unnecessary burdens associated with FDA regulatory activities, patients may have earlier and continued access to beneficial products. Read more “FDA releases draft guidance on the least burdensome approach to regulating devices”
Latest EMA Management Board meeting provides update on Brexit preparations
The European Medicines Agency (EMA) has just over 15 months to prepare for the move to Amsterdam by 30th March 2019. The Management Board of the EMA held a meeting to discuss how the Agency is preparing for the relocation to Amsterdam, and operationally for the United Kingdom’s (UK) withdrawal from the European Union (EU). Read more “Latest EMA Management Board meeting provides update on Brexit preparations”
FDA releases draft guidance on gluten labelling for drugs
The US Food and Drug Administration (FDA) has released draft guidance which encourages drug manufacturers to provide detailed labelling regarding whether their products are made from ingredients that contain gluten. Read more “FDA releases draft guidance on gluten labelling for drugs”