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October 18, 2016
The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.
FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.
October 13, 2016
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
October 11, 2016
HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.
October 10, 2016
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.
October 05, 2016
Value assessment initiatives are expected to have a major impact on drug use and reimbursement.
October 03, 2016
FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.
he guidance addresses the good manufacturing practice for managing quality in APIs.
October 02, 2016
Efforts to accelerate drug development will alter fee structure and require ready production sites.