A California federal court says Amphastar’s whistleblower suit against Aventis alleging fraudulent Medicare and Medicaid claims for Lovenox may continue.
CDER director Janet Woodcock urges Congress to come to terms on legislation to implement an effective national track-and-trace system for all drug products throughout the supply chain.
Goodwin Biotechnology and Coldstream Laboratories agree to collaborate on developing highly-potent and cytotoxic small molecules, protein toxins, cytotoxic antibody drug conjugates, and other bioconjugates.
A new CDER guidance explains how NDA and ANDA applicants address the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.