Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.
Large pharma companies have fallen “below legal and ethical standards” for making public information from the relevant clinical trials, according to a report from Bioethics International.
By Applied Clinical Trials Editors
In this article, Characteristics of a Successful IND, IDE the author discusses ways in which your drug or device could be put on hold.
Ethical GmbH’s Ethical eAdjudication® Platform will be included in ACRES’ shared global platform of integrated technologies.
CDER’s Division of Pharmaceutical Analysis (DPA) will be adopting MasterControl’s full QMS to manage documents, training records, audits, CAPAs, change control, and other quality processes.
This scenario seeks to limit animal and clinical studies to only those needed to eliminate residual uncertainty about product performance. Although innovators maintain that clinical trials still are needed to fully examine immunogenicity and other unique attributes of proteins and monoclonal antibodies, biosimilar developers look to extensive product characterization and to pharmacokinetic (PK) or pharmacodynamic (PD) studies to address these concerns.
In this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.
The Patients Alliance for Drug Safety Protections is comprised of 20 public health, patient advocacy, health professional and disease organizations. To underscore the value of REMS to public health, the Alliance unveiled a new online resource.