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The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient’s performance status, laboratory values, and washout periods.

The European Medicines Agency (EMA) has issued notices stating how it will comply with certain stakeholder information protection under the Data Protection Regulation for EU institutions, bodies, offices, and agencies (EUDPR). Under the regulation that went into effect in 2018, also known as EU 2018/1725, the agency said it is responsible for managing and protecting information received from stakeholders through registration forms and online surveys.

Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.

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

Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council for Harmonisation (ICH), and the US Food and Drug Administration (FDA).

By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked to review to the list of bulk drug substances that can be used in pharmacy compounding.

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 acting FDA commissioner wrote an op-ed promoting the agency’s efforts to incentivize domestic drug manufacturing, FDA announced new grants for using digital health technologies (DHT) for drug development, and it approved an over-the-counter combination of two popular pain drugs.

An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound treatment and inflammatory conditions – be added to the list of drugs eligible for bulk compounding, known as the 503A Bulks List.

Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the time of approval. Of those, the vast majority of study results were published in ClinicalTrials.gov or another publication, according to an article published Thursday in JAMA Network Open.

The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.