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The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change in regulatory policy, reflecting advancements in science and technology that offer alternative testing methods.
The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug or biologic, as another chapter in its evolution toward the use of real-world evidence (RWE).
For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent protection for emerging biotech companies with patent agent Emily Coury.