Regulatory Focus

Patients who reviewed and signed a patient agreement form (PAF) for mifepristone and misoprostol under the US Food and Drug Administration’s (FDA) risk evaluation and mitigation strategy (REMS) program were equally knowledgeable about medication abortion compared to patients who completed a knowledge survey before reviewing and signing the PAF, according to the results of a recent randomized controlled trial published in JAMA Internal Medicine.

Australia’s Therapeutic Goods Administration (TGA) is holding consultations on information sharing under clinical trial schemes and its proposed comments on an international guideline for good clinical practice (GCP).

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

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The US Food and Drug Administration (FDA) issued revised draft guidance on Thursday aimed at assisting sponsors of drug-device combination products in designing and developing essential drug delivery device performance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