Regulatory Focus

The US Food and Drug Administration (FDA) has updated its seven-year-old guidance to clarify the differences among abbreviated approval pathways and the data it will accept for these applications. These pathways include the traditional Abbreviated New Drug Application (ANDA) process under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the 505(b)(2) pathway.

While there have been growing concerns in recent years about whether FDA decision-making might be influenced by external factors, research suggests measuring such influence is a complex task.

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Drug, regulatory, and laboratory animal testing groups want the US Food and Drug Administration (FDA) to ensure flexibility in choosing when to rely on animal testing and when other forms of data may be sufficient for cancer drug safety studies.

More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices suggests the need for greater postmarket surveillance, according to the results of a recent cross-sectional study published in JAMA.

The US Food and Drug Administration (FDA) has updated its guidance for the industry on assessing the quality and safety of container and closure systems (CCS) used to package new drugs and biologics. This marks the first update from the agency in 27 years.

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

The Saudi Food and Drug Authority (SFDA) has launched the New Accelerator Program for Drugs in Rare Diseases (NADR) to streamline the development, evaluation, and authorization of drugs for rare diseases.