Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
Artikel konnten nicht hinzugefügt werden
Der Titel konnte nicht zum Warenkorb hinzugefügt werden.
Der Titel konnte nicht zum Merkzettel hinzugefügt werden.
„Von Wunschzettel entfernen“ fehlgeschlagen.
„Podcast folgen“ fehlgeschlagen
„Podcast nicht mehr folgen“ fehlgeschlagen
Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
-
Gesprochen von:
-
Von:
Über diesen Titel
In this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they discuss the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability, specifically in areas such as cybersecurity, tariffs, DEI compliance, and CID/subpoena responses; key considerations in determining whether to enter into a consent decree with the agency; trends in enforcement discretion; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
To subscribe or find out more information about our podcast, visit FDAWatch.net.
Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.
Music by Dvir Silver from Pixabay.
