Regulatory Authority Actions

Pharmaceutical Technology spoke with Monica Caphart, FDA, and Susan Schniepp, PDA, about the 2015 PDA/FDA Joint Regulatory Conference taking place in Washington, DC, in September.

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

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

The agency streamlines risk and mitigation information.

The agency launches initiative to stimulate pediatric drug development.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

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.

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

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

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

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

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The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

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

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

Industry and regulatory agencies continue to make progress in establishing quality metrics for the pharmaceutical industry.

Integrating advances in facility design can meet differing and emerging bioprocessing needs.