Author's posts
Not With A Bang, But A Whimper . . . FDA Capitulates On Off-Label Regulation
A recent statement by FDA senior official Janet Woodcock suggests that while the FDA is reluctant to litigate over the scope of First Amendment commercial speech and will limit its challenges to industry promotional practices going forward, companies c…
In Pharma Patent Disputes, Data Rules Over Intuition And (Gasp!) Legal Judgment
In patent disputes between branded and generic firms, companies could benefit from having access to data that would help to predict the outcome of litigation rather than relying solely on legal judgment and intuition.
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