Standards & Regulations

Sep 08, 2017
Six years after the guidance, it’s time to change our quality assurance vocabulary.
Sep 02, 2017
Pharmaceutical Technology
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
Sep 02, 2017
Pharmaceutical Technology
When it comes to getting the best out of quality by design, timing is everything.
Sep 02, 2017
Pharmaceutical Technology
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Sep 02, 2017
Pharmaceutical Technology
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Sep 01, 2017
Pharmaceutical Technology
Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
Sep 01, 2017
By Pharmaceutical Technology Editors
A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
Sep 01, 2017
By Pharmaceutical Technology Editors
FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.
Sep 01, 2017
By Pharmaceutical Technology Editors
Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.
Aug 28, 2017
By Pharmaceutical Technology Editors
FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.
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