Provides regulatory counseling regarding: pre-clinical and clinical development strategies; bioequivalence and therapeutic equivalence standards; Abbreviated New Drug Application (ANDA) and 505(b)(2) New Drug Application (NDA) strategies; product classification and regulatory approval pathways; strategic use of FDA meeting opportunities; dispute resolution; labeling negotiations; and appeals of adverse FDA review decisions.
){kind=logo}
Email has been submitted successfully. Thanks!
Error sending the email. Please try again later.