JD Supra26m
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
Healio8h
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
GlobalData on MSN8h
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
JD Supra21h
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
Teva's Growth Profile Looks Strong From Innovative Portfolio, Biosimilar Approvals and Deep Pipeline
We assign Teva a Morningstar Uncertainty Rating of High, which largely reflects our quantitative analysis of the firm, based on the return ranges used by our star rating system, as well as our ...