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By: Sidley Austin LLP

Latest from GoodLifeSci - Page 3

The Trump administration’s Executive Order entitled, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” notes a desire to bolster supply chains, enhance national security, and ensure compliance with evolving regulatory frameworks. Nevertheless, the decision to relocate manufacturing operations for U.S. Food and Drug Administration (FDA)-approved drugs is fraught with regulatory obligations – including those…

A new policy document from the U.K. Government makes the life sciences sector a major focus for changes aimed at facilitating industrial growth. Marie Manley and Dr. Kwabena Tenkorang explain the relevant proposed changes, including reforms to speed up clinical trials, regulatory reforms, the introduction of low-friction procurement and the creation of a Health Data…

Three recent U.S. Executive Orders have significant consequences for India with its outsized role in global generic drug supply. The policy changes offer both opportunity and increased scrutiny for Indian drug manufacturers. Arif Noorani and Ryan Tan discuss proactive steps manufacturers can take. 
The post U.S. Executive Orders Shine Spotlight on India’s Life Sciences Industry…

The 5th Annual Boston Life Sciences Roundtable, “Navigating New Frontiers,” brought together legal experts, industry leaders, and innovators for an afternoon of thought-provoking discussion, strategic networking, and forward-looking perspectives on the latest trends and hot topics shaping the industry. Discussions ranged from recent changes at the FDA to strategies on how to de-risk supply chains…

Recent UK regulatory developments of potential interest to international life sciences companies include: reforms aimed at speeding up medicines approvals and market access, global firsts with respect to certain orphan drug and cancer diagnostic approvals, and updates on unified packaging and labeling across the UK. Article authored by Dr. Chris Boyle and Dr. Kwabena Tenkorang.…

The use of artificial intelligence and machine learning (AI/ML) in drug discovery and development is well established and here to stay. With AI tools developing the potential to impact virtually every stage of the life sciences product life cycle, the FDA continues to refine its framework for the use of AI to support regulatory decision-making.…

Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr.
The post “Refreshed” UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open appeared first on GoodLifeSci.

Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin B. Correa and Kathy P. Lee.
The post Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need…