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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA announced that its drug center and inspections office have agreed to a new concept of operations (ConOps) for coordinating inspections and other compliance activities, a senator released draft legislation that would give FDA new authorities for overseeing artificial intelligence (AI), and the agency has removed a boxed warning from the labels of estradiol patches.

The US Food and Drug Administration (FDA) issued revised draft guidance on Thursday aimed at assisting sponsors of drug-device combination products in designing and developing essential drug delivery device performance characteristics (EDDCs) for their products.

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The US Food and Drug Administration (FDA) on Tuesday issued draft guidance on submitting investigational device exemption (IDE) applications electronically using the electronic Submission Template and Resource (eSTAR) template.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The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to overseeing individualized gene editing (GE) products, including those that feature multiple product variants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.