Regulatory Focus

Stakeholders are urging the US Food and Drug Administration (FDA) to be flexible in how it regulates psychedelic drugs that may help treat conditions such as major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). The agency should be careful not to create unnecessary barriers to patient access, promote proper training and credentialing, and allow flexibility in updating labeling as additional knowledge becomes available, according to individuals and groups that commented via a public docket.

Broader adoption of cloud-based platforms by regulatory bodies could lead to significantly faster approval times, according to a study authored by Nina Cauchon of Amgen and colleagues published in the Journal of Pharmaceutical Sciences.

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

The number of clinical trials authorized in the EU and European Economic Area (EEA) has decreased by 13.5% from pre-pandemic levels as Asia has captured a growing share of clinical research.

The US Food and Drug Administration (FDA) last week finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines and to better address manufacturing changes for interchangeable products, which were not addressed by earlier guidance.

The Pharmaceuticals and Medical Devices Agency (PMDA) has published advice on ensuring the safety of healthy adult participants in Japanese bioequivalence studies.

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, the Department of Health and Human Services (HHS) announced an agency-wide initiative to study and address vaccine injuries, and the congressional committees that oversee FDA could see high turnover after the midterm elections.