Regulation

Generics industry sets record for U.S. approvals, has ‘nothing to apologize for’

Download the full report. At the 2018 Association for Accessible Medicines (AAM) annual meeting, experts highlighted the generic industry’s recent accomplishments while noting that many challenges lie ahead. On the positive side for the industry, as noted by Jeff Watson, chairman, president and COO of Apotex, a controversial rule change regarding generic drug labeling in […]

Health technology assessment agencies play pivotal role in patient access to medicines

Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensuring patient access to the medicines they need, a study by the Centre for Innovation in Regulatory Science (CIRS) has confirmed. As part of an ongoing effort to monitor regulatory and HTA performance, CIRS collected data on new active substances (NASs) […]