Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production International 40

Agency IQ

JUNE 7, 2024

FDA’s new guidance explains what to do during a BIMO inspection Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. In short, the BIMO program oversees regulated research – both human and animal – in a variety of ways.

FDA 40

FDA Compliance Regulations Laboratories 40

Codon

JANUARY 21, 2024

The European Medicines Agency (EMA) is similar in this regard, although interestingly, that’s not the case in the United Kingdom, where regulators are not so directly involved in assessing a challenge study beforehand. There have been deaths in phase 1 medical and drug research among healthy participants.

Vaccine 111

Vaccine Trials Disease Treatment 111

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. countries examined between 2010 and 2017. See also AgencyIQ’s analysis of the leaked draft impact assessment.]

Marketing 40

Marketing Regulations Biosimilars Drugs 40