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The European Commission has adopted new harmonized standards for medical devices and diagnostics but established a five-year transition period to give manufacturers time to adapt their processes.

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Philadelphia – Officials from the US Food and Drug Administration (FDA) discussed strategies for integrating artificial intelligence (AI) with real-world evidence (RWE) to advance drug development during a panel discussion at the DIA Global Annual Meeting on Tuesday. The officials noted there have been an increasing number of submissions that utilize both AI and RWE.

The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to meet quality system and current good manufacturing practice (CGMP) requirements. The agency has also cited more than two dozen telehealth companies for marketing compounded glucagon-like peptide-1 (GLP-1) receptor agonist drugs without authorization.

PHILADELPHIA – The US Food and Drug Administration’s (FDA) publication of complete response letters (CRLs) for unapproved drugs violates the agency’s own regulations and the Administrative Procedure Act, asserted Eva Temkin, an attorney with Arnold & Porter who spoke at the DIA Global Annual Meeting on Monday.

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The US Food and Drug Administration (FDA) has published draft guidance for applicants for new drug applications (NDAs) and NDA holders on submitting patent information to their NDAs using Form FDA 3542a or Form FDA 3542. The guidance is intended to help applicants and holders submit patent information using the correct form to their NDA and aims to answer commonly asked questions.

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on its plans to publish good manufacturing practice (GMP) certificates and inspection outcomes.

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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. A key Senate committee will consider several important pieces of legislation that affect the healthcare products industry next week, FDA has approved a new sunscreen for the US market, and the agency published several guidances, including one on developing human genome editing products.