Regulatory Insights
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The Criticality Of CMO Selection For Small Biopharma Companies
10/29/2023
Delve into the criteria that small or early-stage biopharma companies should consider during their CMO selection process, along with key considerations to keep in mind.
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Feedback On FDA’s eSystems, Records, And Signatures Guidance
10/27/2023
Review this collection of industry feedback received during the Clinical Operations Retreat for Executives where leaders discussed the FDA's latest draft guidance in an interactive workshop.
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Good Manufacturing Practices: When Do They Apply?
10/26/2023
Explore expectations set by the U.S. Food and Drug Administration (FDA) regarding the implementation of current Good Manufacturing Practices standards for investigational drugs.
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Crafting An Effective Commercialization Strategy For CGTs
10/25/2023
Patient access and manufacturing efficiency persist as barriers to widespread adoption of CGTs. An effective commercialization strategy is crucial to expand access to these life-changing therapies.
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An Overview Of Health Canada's CTA Process
10/24/2023
Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.
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The Advantages Of Conducting Early Phase Trials In North America
10/24/2023
In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.
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Moving From Clinical Development To BLA Through Strategic Planning
10/23/2023
Uncover how a small biotechnology company was able to successfully file its Biologics License Application submission to the U.S. Food and Drug Administration after undergoing several personnel losses and shifts.
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FDA’s Draft Guidance On Psychedelic Drugs Raises Questions
10/23/2023
Explore how the U.S. Food and Drug Administration's draft guidance for industry on “Psychedelic Drugs: Considerations for Clinical Investigations" intends to support the ethical conduct of trials, uphold trial integrity, and ensure the reliability of trial results.
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Risk-Based Approach To Monitoring Of Clinical Investigations
10/23/2023
Delve into four key themes found within the FDA's recent guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry."
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Early Collaboration With FDA For Novel Programs: Maximizing ETP
10/23/2023
Get an overview of the U.S. Food and Drug Administration’s collaborative Emerging Technology Program within the Center for Drug Evaluation and Research, enrollment criteria, and benefits.