Regulatory Focus

The Department of Health and Human Services (HHS) has announced that it will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug substances, provided they adhere to specific conditions outlined in an interim policy.

The European Medicines Agency (EMA) and its African counterpart have published a joint position paper to support the timely start of Ebola vaccine clinical trials.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance on submitting investigational device exemption (IDE) applications electronically using the electronic Submission Template and Resource (eSTAR) template.

BOSTON – An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and reviewed some of the changes related to de novos being proposed under the Medical Device User Fee Amendments (MDUFA VI) program at The MedTech Conference last week.

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to overseeing individualized gene editing (GE) products, including those that feature multiple product variants developed under a single investigational new drug application (IND).

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease development and incorporating the patient voice into scientific reviews for orphan therapies during a fireside chat at the NORD Breakthrough Summit on Monday.