Regulatory Oversight and Compliance

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

New guidance complements ICH guidelines on impurities.

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

FDA issues a Form 483 following inspection of Impax Laboratories' Hayward, CA facility.

Novartis announces that its lung cancer drug, Zykadia, gained European Union approval.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Pharma can boast of big-picture successes, but needs to work on operational issues.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.

The agency has recommended granting marketing authorization for Opdivo.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

The European Medicines Agency releases findings from marketing authorization application analysis.