OR WAIT null SECS
Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
October 20, 2016
FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.
October 05, 2016
Value assessment initiatives are expected to have a major impact on drug use and reimbursement.
October 02, 2016
Efforts to accelerate drug development will alter fee structure and require ready production sites.
September 15, 2016
Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.
September 12, 2016
Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
September 02, 2016
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.