FDA publishes draft guidance on CMC changes to a biologics license application

The US Food and Drug Administration (FDA) has published draft guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in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 Read more “FDA publishes draft guidance on CMC changes to a biologics license application”

FDA releases draft guidance on investigational IVDs used in clinical investigations of therapeutic products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 Read more “FDA releases draft guidance on investigational IVDs used in clinical investigations of therapeutic products”

FDA releases draft guidance on information requests and discipline review letters

The US Food and Drug Administration (FDA) has released draft guidance which establishes a new type of letter the agency sends to generic drug manufacturers to provide applicants with initial thoughts on possible deficiencies of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 Read more “FDA releases draft guidance on information requests and discipline review letters”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”

FDA releases draft guidance on the least burdensome approach to regulating devices

The US Food and Drug Administration (FDA) have published draft guidance detailing updates to its least burdensome approach to regulating devices.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”