Michelle MaskalyMedical Device/Packaging3-D printed rib reduces risk for cancer patientThe first-of-its-kind medical device prevents some of the complications associated with the typical treatment.September 13, 2015Adherence/DeliveryFDA accepts first digital medicine new drug applicationThe combination product treats serious mental illness, includes an ingestible sensor in a single tablet, and is supposed to help with patient adherence.September 13, 2015HomeDrug labeling required in 5 languages approved by legislatureIf signed by the governor, information would have to be provided in Spanish, Tagalog, Chinese, Vietnamese or Korean.September 12, 2015Medical Device/PackagingFDA releases Medical Device Single Audit Program status reportThe pilot program's objectives include developing the infrastructure, processes, training, and stakeholder commitment necessary to launch the operational phase.September 11, 2015Pharmaceuticals30,000-year-old virus discovered in melting iceAs long as it poses no threat to humans or animals, scientists plan to wake up the virus so they can study it.September 10, 2015PharmaceuticalsDrug company sues FDA over marketing restrictionsThe company's lawsuit comes after the agency sent them a warning letter last year.September 9, 2015PharmaceuticalsKorea approves Samsung's first biosimilarThe approval represents the first product approval under Merck’s collaboration with Samsung Bioepis.September 9, 2015Medical Device/PackagingOpenFDA expands medical device data accessThe agency hopes the move will spark innovation.September 9, 2015Medical Device/PackagingCollege art students design children's medical deviceArt students at Florida State University are walking away from the canvas and into the science labs.September 9, 2015Adherence/DeliveryFDA rethinking "black box" label for opiatesA newly released letter sheds light on the possible change.September 2, 2015Previous PagePage 17 of 39Next PageTop StoriesSupply ChainFDA Launches PreCheck to Accelerate Domestic Drug Facility ApprovalsThe two-phase program is designed to expedite the approval of new pharmaceutical manufacturing facilities in the U.S. by providing enhanced regulatory guidance and communication to manufacturers.PharmaceuticalsPharmaceutical Packaging Innovations Report Video InterviewTraceability/SerializationThrough the Line Podcast: Improving DSCSA Data Exchange AccuracyPMMI News2025 Packaging State of the Industry: U.S. Expands, Canada MaintainsSupply ChainWhy Is Supply Chain Visibility and Transparency More Critical Now Than Ever Before?
