Industry News

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.

The 12th Annual Report and Survey of Biomanufacturing is now available.

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

The agency takes action against websites that illegally sell unapproved medications.

The International Conference on Harmonization finalizes Q&A document on APIs.

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.

The agency streamlines risk and mitigation information.

The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.

The agency launches initiative to stimulate pediatric drug development.

CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

CPhI Pharma Insights’ Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

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

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

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

Michiel E. Ultee of Ulteemit BioConsulting discusses converting an early drug discovery into a product that is ready for clinical testing.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

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

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.