Medical Device Legal News with Sam Bernstein: Episode 11
Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more
Late last year we covered a decision finding a mine operator could not be held liable for unpermitted discharges under the Clean Water Act because it had properly disclosed them to the state permitting authority, which “chose...more