Regulatory Oversight and Compliance

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The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.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The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.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The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.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.

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.